CompletedNCT01751646Updated Mar 27, 2019Results posted

Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART

An interventional study of Vitamin D3 50,000 IU and Vitamin D3 placebo in HIV Infection, sponsored by University of North Carolina, Chapel Hill. Completed at 17 sites in 2 countries. Open to participants aged 16 Years to 24 Years. Per ClinicalTrials.gov, last updated 2019-03-27.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 214
Allocation: Randomized
Ages: 16 Years to 24 Years
Sex: All

Study summary

This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of adolescents and young adults with HIV infection in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) who are currently being treated with cART that includes tenofovir disoproxil fumarate (TDF) as one component of the regimen that includes at least three Food and Drug Administration (FDA)-approved antiretroviral (ARV) drugs for at least 180 days.

Read the detailed description

This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of adolescents and young adults with HIV infection in the ATN who are currently being treated with cART that includes TDF as one component of the regimen that includes at least three Food and Drug Administration (FDA)-approved ARVs for at least 180 days. Subjects must have at least one documented viral load that is below 200 copies/mL that is collected following initiation of TDF containing cART and greater than 90 days prior to randomization; no viral load above 200 copies/mL if measured within the 90 days prior to randomization; and an HIV viral load obtained at screening that is below 200 copies/mL.

Treatment assignments will be balanced by subject sex at birth, age (\<20 years vs. >=20 years), and race (African American vs. other). Enrolled subjects will be randomized to receive vitamin D3 50000 IU or matching placebo, given orally every four weeks by DOT. In addition to the randomized study agent, all subjects will receive a MVI to be taken orally once daily. This "standard" MVI will contain ingredients not to exceed 600 IU of vitamin D3 and 200 mg Ca.

Dual energy x-ray absorptiometry (DXA) measurement of bone mineral content (BMC)/bone mineral density (BMD) of whole body, spine, and hip, will be performed at baseline and study weeks 24 and 48. Blood and urine sampling to assess the Ca-phosphorous (PO4) axis, parathyroid hormone (PTH)-FGF23-vitamin D signaling, bone turnover, and renal glomerular and tubular function will occur at baseline and study weeks 12, 24, and 48. Blood samples to measure Gluc homeostasis will be drawn at baseline and week 48, and will be run by batch analysis.

Safety, measured by serum calcium (SCa) and serum creatinine (SCr), will be monitored by subject's record review at study sites since these labs will generally be measured as a part of routine clinical care. The Adolescent Medicine Trials Network for HIV/AIDS Interventions 109 (ATN 109) study will use the SCa and SCr values obtained within 10 weeks at the time of the visit beginning at the baseline visit. If these evaluations were not performed within the prior 10 weeks they will be drawn at the time of each visit. Viral load and cluster of differentiation 4 (CD4) cell count results will be recorded for this study, ATN 109, at screening, baseline and study weeks 12, 24, 48, and Post-Week 48 provided the evaluations were done within the protocol specified timeframe. If the evaluations were not performed within the protocol specified timeframes they will be drawn at the time of the visit.

Conditions studied

HIV Infection

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 214 is above the median of 120 across 4,201 interventional studies indexed under Infections.

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Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 24 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

To be considered eligible for enrollment, an individual must meet the criteria listed below at the time of randomization:

NOTE: If the DXA scan is scheduled prior to randomization, all eligibility criteria must be met prior to performing the DXA scan.

Age 16 years and 0 days to 24 years and 364 days;
Behaviorally infected with HIV (e.g., sexual contact, injection drug use; not infected by perinatal transmission, blood transfusion, or at age younger than 9 years);
HIV-1 infection as documented in subject's medical record by at least one of the following criteria:
- reactive HIV screening test result with an antibody based FDA-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 Indirect Immunofluorescence, Antibody Differentiation Assay (Multispot)); or
- positive HIV-1 DNA polymerase chain reaction (PCR) assay; or
- plasma HIV-1 quantitative RNA assay >1,000 copies/mL; or
- positive plasma HIV-1 RNA qualitative assay
Subjects must have at least one documented HIV viral load that is below 200 copies/mL collected following initiation of TDF containing cART and greater than 90 days prior to randomization; no HIV viral load above 200 copies/mL if measured within the 90 days prior to randomization; and an HIV viral load obtained at screening that is below 200 copies/mL.
Currently being treated for at least 180 days by the time of randomization with a TDF containing cART with at least 2 other FDA approved ARVs (NOTE: This may include a TDF-containing fixed drug combination medication);
Negative serum hepatitis B surface antigen (HBsAg) at screening or by history within 4 weeks prior to screening (see section 7.1.3);
Willingness and ability to remain on the same cART regimen for the duration of study participation;
Willingness and ability to participate in the study, follow all study procedures for the duration of study participation, and provide written informed consent or assent with parental permission, if applicable; and
For females of child-bearing potential, agreement to use a minimum of one proven-effective method of birth control and willingness to postpone pregnancy for the duration of study participation (see section 5.3.2 for permitted hormonal contraceptives)

Exclusion criteria

Exclusion Criteria:

To be considered eligible for enrollment, an individual must not meet any of the criteria listed below at the time of randomization:

NOTE: If the DXA scan is scheduled prior to randomization, all eligibility criteria must be met prior to performing the DXA scan.

Prior hypersensitivity to vitamin D;
History of sarcoidosis, arteriosclerosis, renal stones, glomerulonephritis, interstitial kidney disease, nephrotic syndrome, hypercalcemia, osteoporosis and/or other bone diseases, clinical diagnosis of hypoparathyroidism or hyperparathyroidism;
Lactation or pregnancy currently or within the past 24 weeks;
Chemotherapy or radiation therapy for malignancy within the past 12 months;
Known presence of GI disease that, in the opinion of the clinician, would interfere with study agent administration or absorption (e.g. Crohn's, Colitis);
For subjects ≥ 18 years, confirmed creatinine clearance \< 70 ml/min (estimated glomerular filtration rate (GFR) from SCr using Cockcroft and Gault (CG) equation) and for subjects \<18 years, confirmed creatinine clearance \< 70ml/min/1.73m2 (estimated GFR from SCr using Schwartz formula (see section 3.5). (Estimated GFR may be calculated using the formulae programmed on the ATN website);
SCa > Upper Limit Normal (ULN) for local laboratory values (see section 7.1.3);
Active Grade 3 or higher clinical or laboratory toxicity except atazanavir (ATV) associated indirect hyperbilirubinemia (see section 9.5.2.2);
Weight is > 350 pounds (lbs) or 159 kilograms (kgs);
Positive hepatitis C antibody by history or at screening (see section 7.1.3); and
Use of any medications as specified in sections 5.3.1, 5.3.3 and 5.4.
Females Only: Use of certain hormonal contraceptives as specified in the protocol.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 214 participants (actual)

Study arms

Experimental
Group A: Vitamin D3 50,000 IU
Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily.
Dietary Supplement: Vitamin D3 50,000 IU
Placebo comparator
Group B: Vitamin D3 placebo
Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily.
Dietary Supplement: Vitamin D3 placebo

Interventions

Dietary supplementVitamin D3 50,000 IU
Group A: Vitamin D3 50,000 IU orally every four weeks by DOT
Also known as: Vitamin D3
Dietary supplementVitamin D3 placebo
Group B: Vitamin D3 placebo orally every four weeks by DOT
Also known as: Placebo

What researchers measure

Primary outcomes

Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups
Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups. Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit.
Time frame: Baseline and wk 48

Secondary outcomes

Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups
Time frame: Baseline and week 24
Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups
Time frame: Baseline and week 48
Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups
Time frame: Baseline and week 24
Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 24
Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 48
Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups
Time frame: Baseline and week 24
Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups
Time frame: Baseline and week 48
Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 24
Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 48
Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups
Time frame: Baseline and week 24
Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups
Time frame: Baseline and week 48
Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 24
Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups
The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.
Time frame: Baseline and week 48
Change in SCr From Baseline to Week 12.
To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group;
Time frame: Baseline and week 12
Change in SCr From Baseline to Week 24.
To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group;
Time frame: Baseline and week 24
Change in SCr From Baseline to Week 48.
To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group;
Time frame: Baseline and week 48
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)
Time frame: Baseline and 48 weeks
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)
Time frame: Baseline and week 48
Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))
HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of \>2 for any insulin resistance, but "normal" values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance).
Time frame: Baseline and week 48
Change From Baseline to Week 12 in Serum Calcium (SCa)
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in Serum Calcium (SCa)
Time frame: 24 weeks
Change From Baseline to Week 48 in Serum Calcium (SCa)
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in CTX
Time frame: Baseline and week 12
Change From Baseline to Week 24 in CTX
Time frame: Baseline and week 24
Change From Baseline to Week 48 in CTX
Time frame: Baseline and week 48
Change From Baseline to Week 12 in OC
Time frame: Baseline and week 12
Change From Baseline to Week 24 in OC
Time frame: Baseline and week 24
Change From Baseline to Week 48 in OC
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in BAP
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in BAP
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in BAP
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in FGF23
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in FGF23
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in FGF23
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in PTH
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in PTH
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in PTH
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in Actual Free 1,25-OHD
Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in Actual Free 1,25-OHD
Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in Actual Free 1,25-OHD
Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in 1,25-OHD
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in 1,25-OHD
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in 1,25-OHD
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in 25-OHD
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in 25-OHD
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in 25-OHD
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in TRP %
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in TRP %
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in TRP %
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in SPO4
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in SPO4
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in SPO4
Time frame: Baseline and wk 48
Change From Baseline to Week 12 in UCa/Ucr
Time frame: Baseline and wk 12
Change From Baseline to Week 24 in UCa/Ucr
Time frame: Baseline and wk 24
Change From Baseline to Week 48 in UCa/Ucr
Time frame: Baseline and wk 48
Change in Estimated GFR From Baseline to Week 12.
To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group. eGFR calculated by the CKD-Epi equation for subjects \>=18 years of age, and by bedside Schwartz formula for subjects \<18 years of age
Time frame: Baseline and wk 12
Change in Estimated GFR From Baseline to Week 24.
To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group;
Time frame: Baseline and wk 24
Change in Estimated GFR From Baseline to Week 48.
To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group;
Time frame: Baseline and wk 48
Change in UGluc From Baseline to Week 48
To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group;
Time frame: Baseline and wk 48
Change in URBP/UCr Ratio From Baseline to Week 48
To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group;
Time frame: Baseline and wk 48
Change in UB2MG From Baseline to Week 48
To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group;
Time frame: Baseline and wk 48
Change in UProt/ UCr Ratio From Baseline to Week 48
To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group;
Time frame: Baseline and wk 48
25-OHD Serum Concentration by Randomized Study Group at Week 12
Time frame: Week 12
25-OHD Serum Concentration by Randomized Study Group at Week 24
Time frame: Week 24
25-OHD Serum Concentration by Randomized Study Group at Week 48
Time frame: Week 48
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use
Time frame: Baseline
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use
Time frame: Week 48
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use
Time frame: Baseline and wk 48
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use
Time frame: Baseline
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use
Time frame: Week 48
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use
Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use
Time frame: Baseline and wk 48

Results

Posted Mar 11, 2019

Limitations and caveats

The analysis by efavirenz use and ritonavir use after baseline do not adjust for treatment group (secondary outcome measures 68, 69, 71, and 72). Results post-baseline may differ based on treatment group.

Participant flow

This research was conducted at 17 clinical sites, with accrual opening 10/2012. Due to budgetary constraints, accrual to protocol Version 1.0 was placed on hold 9/1/2013; follow-up visits for subjects on study continued while accrual was on hold. Version 2.0 opened to accrual on 2/2/2015. The study was closed to accrual on 6/3/1015.

Participant flow — Overall Study
Milestone	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Started	109	105
Completed	98	87
Not completed	11	18
Withdrew: Lost to follow-up	5	1
Withdrew: Withdrawal by subject	0	4
Withdrew: Starting hormone therapy	1	0
Withdrew: Missed 4 or more consecutive dot visits	2	3
Withdrew: Inadvertent enrollment	1	1
Withdrew: Moved out of the area	1	5
Withdrew: Inability to attend required visits	0	1
Withdrew: Off study due to multiple obligations	0	1
Withdrew: Fails to comply with study requirements	0	1
Withdrew: Childcare issues	1	1

Outcome measures

PrimaryPercent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups

Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups. Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit.

Time frame:: Baseline and wk 48
Reported as:: Median · percent change

Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups	0.19 (-1.54 to 1.48)	0.09 (-1.49 to 2.61)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.1166 (P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo)

SecondaryPercent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups

Time frame:: Baseline and week 24
Reported as:: Median · percent change

Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups	0.25 (-1.23 to 1.44)	0.07 (-0.82 to 1.09)

SecondaryPercent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups

Time frame:: Baseline and week 48
Reported as:: Median · percent change

Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups	0.08 (-1.47 to 1.47)	0.07 (-1.47 to 0.98)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.8383

SecondaryPercent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups

Time frame:: Baseline and week 24
Reported as:: Median · percent change

Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups	0.94 (-0.72 to 2.16)	0.42 (-1.02 to 1.91)

SecondaryChange From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Time frame:: Baseline and week 24
Reported as:: Median · z-score

Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
z-score	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups	0.00 (-0.10 to 0.20)	0.00 (-0.10 to 0.10)

SecondaryChange From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups

Time frame:: Baseline and week 48
Reported as:: Median · z-score

Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups
z-score	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups	0.00 (-0.10 to 0.10)	-0.10 (-0.30 to 0.20)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.1378

SecondaryPercent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups

Time frame:: Baseline and week 24
Reported as:: Median · percent change

Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups	-0.10 (-2.49 to 1.65)	-0.04 (-2.16 to 2.13)

SecondaryPercent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups

Time frame:: Baseline and week 48
Reported as:: Median · percent change

Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups	-0.30 (-2.63 to 1.73)	-0.11 (-2.45 to 1.96)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.4686

SecondaryChange From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Time frame:: Baseline and week 24
Reported as:: Median · z-score

Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups
z-score	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups	0.00 (-0.20 to 0.10)	0.00 (-0.10 to 0.20)

SecondaryChange From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups

Time frame:: Baseline and week 48
Reported as:: Median · z-score

Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups
z-score	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups	0.00 (-0.20 to 0.10)	0.00 (-0.20 to 0.10)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.7601

SecondaryPercent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups

Time frame:: Baseline and week 24
Reported as:: Median · percent change

Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups	-0.27 (-1.08 to 1.53)	0.00 (-1.14 to 1.46)

SecondaryPercent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups

Time frame:: Baseline and week 48
Reported as:: Median · percent change

Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups
percent change	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups	-0.17 (-2.12 to 1.73)	-0.42 (-1.66 to 0.71)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.3978

SecondaryChange From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups

The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Time frame:: Baseline and week 24
Reported as:: Median · z-score

Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups
z-score	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups	0.00 (-0.10 to 0.10)	0.00 (-0.10 to 0.10)

SecondaryChange From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups

Time frame:: Baseline and week 48
Reported as:: Median · z-score

Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups
z-score	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups	0.00 (-0.10 to 0.10)	0.00 (-0.10 to 0.10)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.1187

SecondaryChange in SCr From Baseline to Week 12.

To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group;

Time frame:: Baseline and week 12
Reported as:: Median · mg/dL

Change in SCr From Baseline to Week 12.
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in SCr From Baseline to Week 12.	0.03 (-0.03 to 0.08)	0.02 (-0.03 to 0.07)

SecondaryChange in SCr From Baseline to Week 24.

To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group;

Time frame:: Baseline and week 24
Reported as:: Median · mg/dL

Change in SCr From Baseline to Week 24.
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in SCr From Baseline to Week 24.	0.02 (-0.03 to 0.08)	0.02 (-0.04 to 0.06)

SecondaryChange in SCr From Baseline to Week 48.

To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group;

Time frame:: Baseline and week 48
Reported as:: Median · mg/dL

Change in SCr From Baseline to Week 48.
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in SCr From Baseline to Week 48.	0.03 (-0.02 to 0.08)	0.01 (-0.03 to 0.07)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.5098

SecondaryChange From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)

Time frame:: Baseline and 48 weeks
Reported as:: Median · uIU/mL

Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)
uIU/mL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)	0.45 (-2.21 to 3.48)	-0.83 (-3.02 to 3.43)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.2550

SecondaryChange From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)

Time frame:: Baseline and week 48
Reported as:: Median · mg/dL

Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)	0.05 (-5.05 to 4.20)	-0.20 (-4.85 to 3.85)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.6499

SecondaryChange From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))

HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of \>2 for any insulin resistance, but "normal" values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance).

Time frame:: Baseline and week 48
Reported as:: Median · units on a scale

Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))
units on a scale	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))	0.07 (-0.56 to 0.82)	-0.15 (-0.80 to 0.83)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.2348

SecondaryChange From Baseline to Week 12 in Serum Calcium (SCa)

Time frame:: Baseline and wk 12
Reported as:: Median · mg/dL

Change From Baseline to Week 12 in Serum Calcium (SCa)
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in Serum Calcium (SCa)	-0.02 (-0.26 to 0.20)	0.08 (-0.14 to 0.25)

SecondaryChange From Baseline to Week 24 in Serum Calcium (SCa)

Time frame:: 24 weeks
Reported as:: Median · mg/dL

Change From Baseline to Week 24 in Serum Calcium (SCa)
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in Serum Calcium (SCa)	-0.04 (-0.26 to 0.16)	0.08 (-0.16 to 0.30)

SecondaryChange From Baseline to Week 48 in Serum Calcium (SCa)

Time frame:: Baseline and wk 48
Reported as:: Median · mg/dL

Change From Baseline to Week 48 in Serum Calcium (SCa)
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in Serum Calcium (SCa)	0.00 (-0.22 to 0.25)	0.04 (-0.12 to 0.26)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.2648

SecondaryChange From Baseline to Week 12 in CTX

Time frame:: Baseline and week 12
Reported as:: Median · mcg/L

Change From Baseline to Week 12 in CTX
mcg/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in CTX	-0.03 (-0.21 to 0.13)	-0.02 (-0.19 to 0.15)

SecondaryChange From Baseline to Week 24 in CTX

Time frame:: Baseline and week 24
Reported as:: Median · mcg/L

Change From Baseline to Week 24 in CTX
mcg/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in CTX	-0.03 (-0.24 to 0.18)	-0.02 (-0.16 to 0.15)

SecondaryChange From Baseline to Week 48 in CTX

Time frame:: Baseline and week 48
Reported as:: Median · mcg/L

Change From Baseline to Week 48 in CTX
mcg/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in CTX	-0.08 (-0.25 to 0.10)	-0.09 (-0.27 to 0.02)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.3728

SecondaryChange From Baseline to Week 12 in OC

Time frame:: Baseline and week 12
Reported as:: Median · mcg/L

Change From Baseline to Week 12 in OC
mcg/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in OC	0.15 (-0.78 to 1.67)	-0.10 (-1.15 to 1.66)

SecondaryChange From Baseline to Week 24 in OC

Time frame:: Baseline and week 24
Reported as:: Median · mcg/L

Change From Baseline to Week 24 in OC
mcg/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in OC	0.09 (-1.06 to 1.46)	-0.22 (-1.43 to 1.12)

SecondaryChange From Baseline to Week 48 in OC

Time frame:: Baseline and wk 48
Reported as:: Median · mcg/L

Change From Baseline to Week 48 in OC
mcg/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in OC	-0.93 (-2.10 to 0.62)	-0.48 (-1.95 to 0.41)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.7825

SecondaryChange From Baseline to Week 12 in BAP

Time frame:: Baseline and wk 12
Reported as:: Median · U/L

Change From Baseline to Week 12 in BAP
U/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in BAP	-1.05 (-4.33 to 1.85)	-1.74 (-3.82 to 0.88)

SecondaryChange From Baseline to Week 24 in BAP

Time frame:: Baseline and wk 24
Reported as:: Median · U/L

Change From Baseline to Week 24 in BAP
U/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in BAP	-2.54 (-5.31 to 0.07)	-2.03 (-4.50 to 0.35)

SecondaryChange From Baseline to Week 48 in BAP

Time frame:: Baseline and wk 48
Reported as:: Median · U/L

Change From Baseline to Week 48 in BAP
U/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in BAP	-2.71 (-6.44 to -0.51)	-2.19 (-5.58 to 1.06)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.1950

SecondaryChange From Baseline to Week 12 in FGF23

Time frame:: Baseline and wk 12
Reported as:: Median · pg/ML

Change From Baseline to Week 12 in FGF23
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in FGF23	3.31 (-2.99 to 9.21)	3.90 (-2.28 to 9.21)

SecondaryChange From Baseline to Week 24 in FGF23

Time frame:: Baseline and wk 24
Reported as:: Median · pg/ML

Change From Baseline to Week 24 in FGF23
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in FGF23	2.93 (-4.07 to 8.35)	3.65 (-4.45 to 10.53)

SecondaryChange From Baseline to Week 48 in FGF23

Time frame:: Baseline and wk 48
Reported as:: Median · pg/ML

Change From Baseline to Week 48 in FGF23
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in FGF23	4.77 (-2.78 to 10.31)	3.15 (-3.75 to 10.15)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.7127

SecondaryChange From Baseline to Week 12 in PTH

Time frame:: Baseline and wk 12
Reported as:: Median · pg/ML

Change From Baseline to Week 12 in PTH
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in PTH	-2.17 (-10.26 to 4.00)	-0.82 (-7.79 to 3.95)

SecondaryChange From Baseline to Week 24 in PTH

Time frame:: Baseline and wk 24
Reported as:: Median · pg/ML

Change From Baseline to Week 24 in PTH
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in PTH	-0.25 (-10.38 to 6.70)	-1.71 (-7.78 to 5.65)

SecondaryChange From Baseline to Week 48 in PTH

Time frame:: Baseline and wk 48
Reported as:: Median · pg/ML

Change From Baseline to Week 48 in PTH
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in PTH	-2.21 (-10.13 to 4.25)	-0.96 (-9.28 to 4.93)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.4676

SecondaryChange From Baseline to Week 12 in Actual Free 1,25-OHD

Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L

Time frame:: Baseline and wk 12
Reported as:: Median · fmol/L

Change From Baseline to Week 12 in Actual Free 1,25-OHD
fmol/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in Actual Free 1,25-OHD	106.50 (-12.50 to 222.13)	53.23 (-28.51 to 148.88)

SecondaryChange From Baseline to Week 24 in Actual Free 1,25-OHD

Time frame:: Baseline and wk 24
Reported as:: Median · fmol/L

Change From Baseline to Week 24 in Actual Free 1,25-OHD
fmol/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in Actual Free 1,25-OHD	98.61 (-29.77 to 242.62)	59.36 (-41.94 to 162.45)

SecondaryChange From Baseline to Week 48 in Actual Free 1,25-OHD

Time frame:: Baseline and wk 48
Reported as:: Median · fmol/L

Change From Baseline to Week 48 in Actual Free 1,25-OHD
fmol/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in Actual Free 1,25-OHD	63.73 (-19.39 to 202.54)	25.66 (-100.82 to 118.45)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.0210

SecondaryChange From Baseline to Week 12 in 1,25-OHD

Time frame:: Baseline and wk 12
Reported as:: Median · pg/ML

Change From Baseline to Week 12 in 1,25-OHD
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in 1,25-OHD	15.61 (-0.32 to 35.18)	6.06 (-7.63 to 25.52)

SecondaryChange From Baseline to Week 24 in 1,25-OHD

Time frame:: Baseline and wk 24
Reported as:: Median · pg/ML

Change From Baseline to Week 24 in 1,25-OHD
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in 1,25-OHD	12.90 (-7.57 to 36.58)	8.58 (-8.96 to 27.02)

SecondaryChange From Baseline to Week 48 in 1,25-OHD

Time frame:: Baseline and wk 48
Reported as:: Median · pg/ML

Change From Baseline to Week 48 in 1,25-OHD
pg/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in 1,25-OHD	10.52 (-2.05 to 31.47)	2.74 (-14.73 to 24.48)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.0144

SecondaryChange From Baseline to Week 12 in 25-OHD

Time frame:: Baseline and wk 12
Reported as:: Median · ng/ML

Change From Baseline to Week 12 in 25-OHD
ng/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in 25-OHD	16.33 (9.33 to 21.19)	6.91 (2.34 to 11.55)

SecondaryChange From Baseline to Week 24 in 25-OHD

Time frame:: Baseline and wk 24
Reported as:: Median · ng/ML

Change From Baseline to Week 24 in 25-OHD
ng/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in 25-OHD	18.60 (10.53 to 25.58)	6.78 (1.35 to 11.24)

SecondaryChange From Baseline to Week 48 in 25-OHD

Time frame:: Baseline and wk 48
Reported as:: Median · ng/ML

Change From Baseline to Week 48 in 25-OHD
ng/ML	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in 25-OHD	17.80 (11.83 to 24.03)	2.64 (-1.66 to 7.52)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = < 0.0001

SecondaryChange From Baseline to Week 12 in TRP %

Time frame:: Baseline and wk 12
Reported as:: Median · percent

Change From Baseline to Week 12 in TRP %
percent	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in TRP %	-0.71 (-3.46 to 2.03)	0.04 (-2.78 to 3.37)

SecondaryChange From Baseline to Week 24 in TRP %

Time frame:: Baseline and wk 24
Reported as:: Median · percent

Change From Baseline to Week 24 in TRP %
percent	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in TRP %	-0.59 (-4.43 to 1.79)	-0.88 (-3.001 to 2.32)

SecondaryChange From Baseline to Week 48 in TRP %

Time frame:: Baseline and wk 48
Reported as:: Median · percent

Change From Baseline to Week 48 in TRP %
percent	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in TRP %	-1.55 (-4.71 to 1.84)	0.62 (-2.92 to 3.06)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.0814

SecondaryChange From Baseline to Week 12 in SPO4

Time frame:: Baseline and wk 12
Reported as:: Median · mg/dL

Change From Baseline to Week 12 in SPO4
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in SPO4	0.00 (-0.34 to 0.26)	0.02 (-0.33 to 0.38)

SecondaryChange From Baseline to Week 24 in SPO4

Time frame:: Baseline and wk 24
Reported as:: Median · mg/dL

Change From Baseline to Week 24 in SPO4
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in SPO4	-0.06 (-0.42 to 0.29)	0.03 (-0.34 to 0.34)

SecondaryChange From Baseline to Week 48 in SPO4

Time frame:: Baseline and wk 48
Reported as:: Median · mg/dL

Change From Baseline to Week 48 in SPO4
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in SPO4	-0.03 (-0.33 to 0.36)	-0.12 (-0.47 to 0.31)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.4808

SecondaryChange From Baseline to Week 12 in UCa/Ucr

Time frame:: Baseline and wk 12
Reported as:: Median · ratio

Change From Baseline to Week 12 in UCa/Ucr
ratio	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 12 in UCa/Ucr	0.00 (-0.02 to 0.04)	0.00 (-0.01 to 0.04)

SecondaryChange From Baseline to Week 24 in UCa/Ucr

Time frame:: Baseline and wk 24
Reported as:: Median · ratio

Change From Baseline to Week 24 in UCa/Ucr
ratio	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 24 in UCa/Ucr	0.01 (-0.01 to 0.05)	0.01 (-0.01 to 0.02)

SecondaryChange From Baseline to Week 48 in UCa/Ucr

Time frame:: Baseline and wk 48
Reported as:: Median · ratio

Change From Baseline to Week 48 in UCa/Ucr
ratio	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change From Baseline to Week 48 in UCa/Ucr	0.00 (-0.01 to 0.03)	0.01 (-0.01 to 0.04)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.3870

SecondaryChange in Estimated GFR From Baseline to Week 12.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group. eGFR calculated by the CKD-Epi equation for subjects \>=18 years of age, and by bedside Schwartz formula for subjects \<18 years of age

Time frame:: Baseline and wk 12
Reported as:: Median · ml/min/1.73m^2

Change in Estimated GFR From Baseline to Week 12.
ml/min/1.73m^2	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in Estimated GFR From Baseline to Week 12.	0.00 (-12.11 to 6.29)	0.00 (-7.49 to 7.18)

SecondaryChange in Estimated GFR From Baseline to Week 24.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group;

Time frame:: Baseline and wk 24
Reported as:: Median · ml/min/1.73m^2

Change in Estimated GFR From Baseline to Week 24.
ml/min/1.73m^2	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in Estimated GFR From Baseline to Week 24.	0.00 (-15.24 to 2.43)	0.00 (-10.42 to 7.71)

SecondaryChange in Estimated GFR From Baseline to Week 48.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group;

Time frame:: Baseline and wk 48
Reported as:: Median · ml/min/1.73m^2

Change in Estimated GFR From Baseline to Week 48.
ml/min/1.73m^2	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in Estimated GFR From Baseline to Week 48.	-1.91 (-15.67 to 3.70)	0.00 (-10.96 to 5.65)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.4290

SecondaryChange in UGluc From Baseline to Week 48

To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group;

Time frame:: Baseline and wk 48
Reported as:: Median · mg/dL

Change in UGluc From Baseline to Week 48
mg/dL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in UGluc From Baseline to Week 48	-0.42 (-3.27 to 3.23)	-0.43 (-3.17 to 2.62)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.9186

SecondaryChange in URBP/UCr Ratio From Baseline to Week 48

To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group;

Time frame:: Baseline and wk 48
Reported as:: Median · mcg/g

Change in URBP/UCr Ratio From Baseline to Week 48
mcg/g	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in URBP/UCr Ratio From Baseline to Week 48	-1.06 (-37.77 to 32.56)	-4.72 (-33.97 to 18.15)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.4016

SecondaryChange in UB2MG From Baseline to Week 48

To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group;

Time frame:: Baseline and wk 48
Reported as:: Median · mcg/L

Change in UB2MG From Baseline to Week 48
mcg/L	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in UB2MG From Baseline to Week 48	5.19 (-95.04 to 111.85)	10.75 (-90.69 to 157.26)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.5810

SecondaryChange in UProt/ UCr Ratio From Baseline to Week 48

To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group;

Time frame:: Baseline and wk 48
Reported as:: Median · ratio

Change in UProt/ UCr Ratio From Baseline to Week 48
ratio	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Change in UProt/ UCr Ratio From Baseline to Week 48	0.00 (-0.02 to 0.01)	0.00 (-0.01 to 0.01)

Statistical analysis

Group A: Vitamin D3 50,000 IU vs Group B: Vitamin D3 Placebo · Wilcoxon (Mann-Whitney) · p = 0.1570

Secondary25-OHD Serum Concentration by Randomized Study Group at Week 12

Time frame:: Week 12
Reported as:: Median · ng/mL

25-OHD Serum Concentration by Randomized Study Group at Week 12
ng/mL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
25-OHD Serum Concentration by Randomized Study Group at Week 12	35.14 (29.79 to 39.76)	23.97 (18.35 to 30.19)

Secondary25-OHD Serum Concentration by Randomized Study Group at Week 24

Time frame:: Week 24
Reported as:: Median · ng/mL

25-OHD Serum Concentration by Randomized Study Group at Week 24
ng/mL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
25-OHD Serum Concentration by Randomized Study Group at Week 24	37.04 (30.41 to 44.12)	23.30 (17.92 to 28.49)

Secondary25-OHD Serum Concentration by Randomized Study Group at Week 48

Time frame:: Week 48
Reported as:: Median · ng/mL

25-OHD Serum Concentration by Randomized Study Group at Week 48
ng/mL	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
25-OHD Serum Concentration by Randomized Study Group at Week 48	36.89 (30.46 to 42.38)	20.55 (14.35 to 25.80)

SecondaryEffect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use

Time frame:: Baseline
Reported as:: Mean · ng/mL

Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use
ng/mL	Efavirenz Use	No Efavirenz Use
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use	17.02 ± 8.69	19.61 ± 9.96

SecondaryEffect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use

Time frame:: Week 48
Reported as:: Mean · ng/mL

Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use
ng/mL	Efavirenz Use	No Efavirenz Use
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use	28.24 ± 11.22	29.68 ± 11.52

SecondaryEffect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use

Time frame:: Baseline and wk 48
Reported as:: Mean · ng/mL

Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use
ng/mL	Efavirenz Use	No Efavirenz Use
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use	10.97 ± 12.00	9.79 ± 11.68

Statistical analysis

Efavirenz Use · Wilcoxon Signed Rank Test · p = <0.0001
No Efavirenz Use · Wilcoxon Signed Rank Test · p = <0.0001

SecondaryEffect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use

Time frame:: Baseline
Reported as:: Mean · ng/mL

Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use
ng/mL	Ritonavir Use	No Ritonavir Use
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use	18.62 ± 8.79	18.69 ± 10.13

SecondaryEffect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use

Time frame:: Week 48
Reported as:: Mean · ng/mL

Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use
ng/mL	Ritonavir Use	No Ritonavir Use
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use	29.46 ± 10.70	28.92 ± 11.89

SecondaryEffect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use

Time frame:: Baseline and wk 48
Reported as:: Mean · ng/mL

Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use
ng/mL	Ritonavir Use	No Ritonavir Use
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use	10.55 ± 11.07	10.02 ± 12.28

Statistical analysis

Ritonavir Use · Wilcoxon Signed Rank Test · p = < 0.0001
No Ritonavir Use · Wilcoxon Signed Rank Test · p = < 0.0001

Adverse events

Collected over Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A: Vitamin D3 50,000 IU	0/109 (0%)	5/109 (4.6%)	6/109 (5.5%)
Group B: Vitamin D3 Placebo	0/105 (0%)	6/105 (5.7%)	8/105 (7.6%)

Most frequent serious events

Most frequent serious events
Event	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
Suicidal ideationPsychiatric disorders	0/109	2/105
CellulitisInfections and infestations	0/109	2/105
Acute psychosisPsychiatric disorders	0/109	1/105
Cellulitis StreptococcalInfections and infestations	0/109	1/105
Suicide attemptPsychiatric disorders	1/109	0/105
Mental Status ChangesPsychiatric disorders	1/109	0/105
AsthmaRespiratory, thoracic and mediastinal disorders	1/109	0/105
Tooth abscessInfections and infestations	1/109	0/105
GastroenteritisInfections and infestations	1/109	0/105

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo
ColitisGastrointestinal disorders	2/109	0/105
Head injuryInjury, poisoning and procedural complications	0/109	1/105
LacerationInjury, poisoning and procedural complications	0/109	1/105
Soft tissue injuryInjury, poisoning and procedural complications	0/109	1/105
Tendon RuptureInjury, poisoning and procedural complications	0/109	1/105
Alanine Aminotransferase IncreasedInvestigations	0/109	1/105
Aspartate Aminotransferase IncreasedInvestigations	0/109	1/105
Blood Bilirubin IncreasedInvestigations	0/109	1/105
Blood Creatinine IncreasedInvestigations	1/109	1/105
Blood Glucose IncreasedInvestigations	0/109	1/105

Baseline characteristics

The baseline analysis population includes all participants randomized to Group A or Group B who received the intervention, with the exception of two participants (one in each group) who were later determined to have been inadvertent enrollments who did not meet eligibility criteria.

Age, Continuous
Age, Continuous(years)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Mean	21.84 ± 1.95	21.85 ± 1.55	21.84 ± 1.76

Sex: Female, Male
Sex: Female, Male(Participants)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Female	18	15	33
Male	90	89	179

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Race — Black	78	79	157
Race — Non-black	30	25	55

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Ethnicity — Hispanic or Latino	21	24	45
Ethnicity — Non-Hispanic or Non-Latino	87	79	166
Ethnicity — Unknown/Not reported	0	1	1

Season Enrolled
Season Enrolled(Participants)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Winter	44	39	83
Spring	43	42	85
Summer	15	18	33
Fall	6	5	11

Lumbar spine bone mineral density (BMD)
Lumbar spine bone mineral density (BMD)(g/cm^2)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Median	1.06 (0.99 to 1.19)	1.08 (0.98 to 1.20)	1.07 (0.99 to 1.19)

Lumbar spine BMD (L1-L4) (Z-score)
Lumbar spine BMD (L1-L4) (Z-score)(z-score)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Median	-0.65 (-1.40 to 0.00)	-0.70 (-1.60 to 0.20)	-0.70 (-1.50 to 0.10)

Total Hip BMD
Total Hip BMD(g/cm^2)	Group A: Vitamin D3 50,000 IU	Group B: Vitamin D3 Placebo	Total
Median	1.06 (0.95 to 1.16)	1.05 (0.95 to 1.17)	1.06 (0.95 to 1.17)

27 further baseline measures are reported on the registry.

Study locations

17 sites

Children's Hopsital of Los Angeles
Los Angeles, California 90027, United States
University of Southern California - NICHD Westat Site
Los Angeles, California 90033, United States
Childrens National Medical Center
Washington, District of Columbia 20010, United States
Children's Diagnostic and Treatment Center - NICHD Westat Site
Fort Lauderdale, Florida 33316, United States
University of Miami School of Medicine
Miami, Florida 33101, United States
University of South Florida
Tampa, Florida 33606, United States
Stroger Hospital and the CORE Center
Chicago, Illinois 60612, United States
Tulane Medical Center
New Orleans, Louisiana 70112, United States
Johns Hopkins University - NICHD Westat Site
Baltimore, Maryland 21287, United States
Johns Hopkins University
Baltimore, Maryland 21287, United States
Fenway Institute
Boston, Massachusetts 02215, United States
Wayne State University
Detroit, Michigan 48201, United States
Montefiore Medical Center
Bronx, New York 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee 38105, United States
Baylor College of Medicine
Houston, Texas 77030, United States
San Juan City Hospital (Puerto Rico) - NICHD Westat Site
San Juan, 00936-5067, Puerto Rico

References and documents

Publications

Havens PL, Stephensen CB, Van Loan MD, Schuster GU, Woodhouse LR, Flynn PM, Gordon CM, Pan CG, Rutledge B, Harris DR, Price G, Baker A, Meyer WA 3rd, Wilson CM, Hazra R, Kapogiannis BG, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 109 Study Team. Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial. Clin Infect Dis. 2018 Jan 6;66(2):220-228. doi: 10.1093/cid/cix753. PubMed 29020329 ↗
Havens PL, Long D, Schuster GU, Gordon CM, Price G, Wilson CM, Kapogiannis BG, Mulligan K, Stephensen CB; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 117 and 109 study teams. Tenofovir disoproxil fumarate appears to disrupt the relationship of vitamin D and parathyroid hormone. Antivir Ther. 2018;23(7):623-628. doi: 10.3851/IMP3269. Epub 2018 Sep 27. PubMed 30260797 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01751646
Lead sponsor: University of North Carolina, Chapel Hill
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
Responsible party: Sponsor
First posted: Dec 18, 2012
Start date: Oct 2012
Primary completion: Jun 2016
Completion: Jun 2016
Results posted: Mar 11, 2019
Last update: Mar 27, 2019

Study contacts

Peter Havens, MD

study chair · MACC Fund Research Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART

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