An interventional study of 25 Hydroxy- Vitamin D3 [25 (OH) D3] and Placebo in Hypovitaminosis D, sponsored by Charles Drew University of Medicine and Science. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Charles Drew University of Medicine and Science · Not applicable, Interventional, and Prevention
Among 228 studies testing cholecalciferol in Vitamin D Deficiency — 9 open to participants now, 16 under way, 2 of them phase 3. Cholecalciferol · Vitamin D Deficiency.
Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, this one is the 21st largest by enrollment, is one of 15 that started in 2013, is one of 113 with no phase, and was the 141st registered.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
Browse Vitamin D Deficiency studies →9 of the 228 studies testing cholecalciferol in Vitamin D Deficiency are open now, in 7 countries. Recruiting first, the newest first:
Aziz Bhatti Shaheed Teaching Hospital · Sites in Pakistan
Ages 6–14
Bangladesh Medical University · Sites in Bangladesh
Ages 20–40 · Men only
National Taiwan University Hospital · Sites in Taiwan
Ages 18+
Peking University First Hospital · Sites in China
Ages 19+
Coordinación de Investigación en Salud, Mexico · Sites in Mexico
Ages 5–17
By country, each count listing its studies:
Cholecalciferol: first FDA approval 2000 (INFUVITE ADULT), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →
Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
228 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 40 · Phase 3 38 · Phase 4 34
First in 2004; this study’s year is marked. 15 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 330 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Median enrollment 72 across the 228 interventional studies. Of the 179 that completed or were terminated, 44 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 228 have an industry lead sponsor. The 10 most frequent:
Charles Drew University of Medicine and Science is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
Charles Drew University of Medicine and Science has 2 studies filed under Vitamin D Deficiency — fewer than ten, so there is no comparison to draw.
6 of the studies testing cholecalciferol in Vitamin D Deficiency that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03188796Phase 3Medical University of GrazThe VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients | 2027-07 |
| NCT04677816Wake Forest University Health SciencesImpact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients | 2026-12 |
| NCT03613116University of California, DavisHigh-dose Vitamin D Supplements in Older Adults | 2026-12-31 |
| NCT07914478Aziz Bhatti Shaheed Teaching HospitalRole of Vitamin D Supplementation in Children With Irritable Bowel Syndrome | 2027-03-30 |
| NCT07006714University of MiamiPreoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) | 2027-07-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 228 studies testing cholecalciferol in Vitamin D Deficiency, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive, African-American participants will be enrolled in a 8 week study to assess the effect of two administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical, biologic and genetic factors. The investigators anticipate that at least 300 participants will complete this study.
Written, signed and dated informed consent to participate in the study will be given by the participant or a legally acceptable representative, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related activities/procedures. The original signed and dated consent will be kept in the subject's research file and a copy given to the subject. A copy will also be placed in their medical record.
DETAILED DESCRIPTION OF STUDY PROCEDURES. Three hundred thirty (330) overweight, pre-hypertensive/controlled hypertensive, African-American participants will be enrolled in a 8 week study to assess the effect of two administrations of Vitamin D3 on Vitamin D serum responsiveness as a function of clinical, biologic and genetic factors. The investigators anticipate that at least 300 participants will complete this study.
Written, signed and dated informed consent to participate in the study will be given by the participant or a legally acceptable representative, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related activities/procedures. The original signed and dated consent will be kept in the subject's research file and a copy given to the subject. A copy will also be placed in their medical record.
BLOOD PRESSURE CONTROL. Controlled high blood pressure is entry criteria, but not an outcome. However, the investigators want to exclude potential participants who are likely to have poor BP control during the study. Therefore, although patients with pre-hypertension or hypertension are eligible to be entered into the study, the protocol only allows enrollment of participants with well-controlled hypertension as defined by SBP≥ 120 mmHg or DBP ≥ 80 mmHg if not on treatment, and SBP \<160 mmHg or DBP \< 100 mmHg regardless of whether on treatment or not. BP care will be managed by the participants' primary or other provider. All participants being actively treated for hypertension with pharmacotherapy will receive direction to adhere to their medication and to follow-up with their Primary Care Physician. Patients with poorly controlled diabetes as defined by hemoglobin A1c > 8.5% or advanced kidney disease as defined by eGFR \< 45 ml/min are excluded. After the study is concluded, all participants will be encouraged and supported to address issues of diet and exercise that may reduce their risk for hypertension. If BP medications need to be adjusted, participants will be referred back to their Primary Care Physician.
VISIT 1 - SCREENING. The screening period will allow for the determination of appropriateness of each subject's inclusion in the study. Written informed consent from the subject or their legally authorized representative would have been obtained prior to any study-related procedures being performed. In addition to signing the general informed consent, subjects who agree to participate the sub-study with fat biopsy will sign a second informed consent.
The subject will be assigned a screening number and will be contacted regarding eligibility once all screening procedures have been performed and laboratory results received.
The following evaluations and assessments will be performed during Screening:
inclusion/exclusion criteria, medical history (including demographics and concomitant medications, including prescription, herbal/vitamins, and all over-the-counter medications), vital signs (sitting BP, heart rate), and a mini physical examination (which will include height (cm), weight (kg), and waist circumference (cm) from which body mass index (BMI) will be calculated and a clinical heart/lung examination. Blood will be drawn (15 cc) for full biochemistry panel with glucose (mg/dl), complete blood count, HbA1c (%), calcium (mg/dl), phosphorus (mg/dl), albumin (mg/dl), pregnancy test and 25(OH)D (ng/ml) levels. After screening information is reviewed and deemed to be appropriate for inclusion in the study, eligible subjects will be given an appointment and preparatory instructions for Visit 2 (Baseline/Randomization/Dose#1). Instructions include cessation of smoking (if they smoke), eating, or drinking caffeine for at least 8 hours prior to the Baseline Visit. If participants are taking prescribed medications, they will be asked to bring them and advised to take them as prescribed.
VISIT 2 - BASELINE/ RANDOMIZATION/ STUDY DRUG DOSE#1 ADMINISTRATION. If subject meets all of the inclusion/exclusion criteria, they will be randomized. The participant will be asked about any adverse events and changes in medications, including prescription, herbal/vitamin, and over-the-counter medications. Vital signs (sitting BP, heart rate) will be obtained and a nutritional survey administered. Blood will be drawn (45 cc) for serum calcium (mg/dl), phosphorus (mg/dl), albumin (mg/dl), iPTH (pg/ml) and 1-84 PTH/7-84 PTH ratio, pregnancy test, 25(OH)D (ng/ml) levels; and samples stored for bio-markers (e.g. pro-inflammatory/pro-thrombotic/fibrotic, insulin sensitivity, and vitamin D receptor polymorphisms). Spot urine sample (30cc) will be collected for calcium/creatinine and albumin/creatinine ratios as well as sodium and isoprostanes. The fat biopsy will be performed on those that agree to be part of the subgroup. Participants undergoing the fat biopsy will be given post biopsy instructions including a return appointment in 7-10 days.
Visit will last about 30-60 minutes for most participants. At the end of the visit, participant will be randomized and given either two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] or two tablets of Placebo (microcrystalline cellulose) to take under direct observation. All the participants will be given an appointment and preparatory instructions for Study Visit 3. They will also be asked to avoid any other vitamin D supplements during study period.
VISIT 3 - STUDY DRUG DOSE#2 ADMINISTRATION (2 weeks after baseline). Visit will last about 15 minutes for most participants. Participant will be asked about any adverse events and changes in medications, including prescription, herbal, and over-the-counter medications. Vital signs will be obtained. Participant will be given their second dose of either two 50,000 IU tablets of oral Vitamin D3 or two tablets of Placebo to take under direct observation. All the participants will be given an appointment and preparatory instructions for Study Visit 4 (Week 6).
VISIT 4 (Week 6). During this visit participant will be asked about any adverse events including possible symptoms of vitamin D overdose and changes in medications, including prescription, herbal, and over-the-counter medications. In addition, the following evaluations and assessments will also be performed: vital signs (sitting BP, heart rate). Blood will be drawn (3 tablespoon or 45 cc) for full biochemistry panel, with glucose (mg/dl), HbA1c (%), complete blood count, calcium (mg/dl), phosphorus (mg/dl), albumin (mg/dl), iPTH (pg/ml) and 1-84 PTH/7-84 PTH ratio, and 25(OH)D (ng/ml) levels; and stored samples for bio markers (e.g. pro-inflammatory/pro- thrombotic/fibrotic, insulin sensitivity, and vitamin D receptor polymorphisms). Spot urine sample will be collected for calcium/creatinine and albumin/creatinine ratios as well as sodium and isoprostanes. Urine pregnancy test will also be done. Participants undergoing the fat biopsy will be given post biopsy instructions and will have an additional 7-10 days of follow-up.
VISIT 5 - END OF STUDY (Week 8). At the End of Study visit (EOS), participant will be asked about any adverse events including possible symptoms of vitamin D overdose. In addition, the following evaluations and assessments will also be performed: vital signs (sitting BP and heart rate). The results of the labs from the previous visit will be discussed and if there are any abnormal lab values, participant will be referred to primary care physician for further management.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Any female of non-, including any female who:
Exclusion Criteria:
Concurrent Disease:
Other:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participant will be randomized to receive two tablets of Placebo (microcrystalline cellulose) to take under direct observation at the baseline and week 2 visit.
Drug: Placebo
The participant will be randomized to receive two 50,000 IU tablets of oral Vitamin D3 \[also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3\] to take under direct observation at the baseline and week 2 visit.
Drug: 25 Hydroxy- Vitamin D3 [25 (OH) D3]
Two 50,000 IU tablets of oral Vitamin D3 \[also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3\] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator.
Also known as: Vitamin D3
Plasma PTH Level
Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either 'nutrient-responsive' or 'nutrient-resistant'. These studies should help identify the 'clinical' characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation.
Time frame: Baseline and Week 6
Vitamin D3 Level
Time frame: Baseline and Week 6
Oxidative Stress Markers: Cysteine
Time frame: Baseline and Week 6
Oxidative Stress Markers: Homocysteine
Time frame: Baseline and Week 6
Oxidative Stress Markers: GSH
Time frame: Baseline and Week 6
Oxidative Stress Markers: Isoprostane
Time frame: Baseline and Week 6
| Milestone | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Started | 111 | 219 |
| Completed | 102 | 202 |
| Not completed | 9 | 17 |
Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either 'nutrient-responsive' or 'nutrient-resistant'. These studies should help identify the 'clinical' characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation.
| pg/ml | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Baseline | 58.29 ± 23.82 | 60.73 ± 26.04 |
| Week 6 | 57.88 ± 22.23 | 54.05 ± 26.12 |
| ng/ml | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Baseline | 17.02 ± 4.51 | 16.55 ± 4.87 |
| Week 6 | 16.64 ± 4.90 | 32.73 ± 7.14 |
| umol/L | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Cysteine (Baseline) | 253.5 ± 41.5 | 252.4 ± 35.6 |
| Cysteine (Week 6) | 249.0 ± 38.7 | 241.2 ± 32.8 |
| umol/L | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Homocysteine (Baseline) | 11.5 ± 3.3 | 11.9 ± 6.1 |
| Homocysteine (Week 6) | 11.0 ± 3.0 | 11.8 ± 4.8 |
| umol/L | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| GSH (Baseline) | 4.1 ± 1.2 | 4.1 ± 1.1 |
| GSH (Week 6) | 3.6 ± 0.9 | 3.5 ± 0.8 |
| pg/ml | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Isoprostane (Baseline) | 8298.6 ± 8504.8 | 11914.9 ± 17904.9 |
| Isoprostane (Week 6) | 687.1 ± 54460.2 | 9979.7 ± 8630.1 |
Collected over Adverse events were collected throughout duration of study = 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/111 (0%) | 1/111 (0.9%) | 5/111 (4.5%) |
| 25 Hydroxy-Vitamin D3 or [25 (OH) D3] | 0/219 (0%) | 0/219 (0%) | 15/219 (6.8%) |
| Event | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/111 | 0/219 |
| Event | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] |
|---|---|---|
| Elevated Blood PressureCardiac disorders | 1/111 | 4/219 |
| Right Leg PainMusculoskeletal and connective tissue disorders | 1/111 | 0/219 |
| Skin Injury - Right Lower Extremity (Pre-Existing)Skin and subcutaneous tissue disorders | 1/111 | 0/219 |
| Left Shoulder Muscle StrainMusculoskeletal and connective tissue disorders | 1/111 | 0/219 |
| GoutMusculoskeletal and connective tissue disorders | 1/111 | 0/219 |
| Abnormal Lab ValueRenal and urinary disorders | 0/111 | 1/219 |
| Fractured Right ArmMusculoskeletal and connective tissue disorders | 0/111 | 1/219 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/111 | 1/219 |
| Neck StrainMusculoskeletal and connective tissue disorders | 0/111 | 1/219 |
| BradycardiaCardiac disorders | 0/111 | 1/219 |
| Age, Continuous(years) | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] | Total |
|---|---|---|---|
| Mean | 53.3 ± 9.7 | 51.3 ± 9.7 | 52.0 ± 9.7 |
| Sex: Female, Male(Participants) | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] | Total |
|---|---|---|---|
| Female | 20 | 25 | 45 |
| Male | 91 | 194 | 285 |
| Race (NIH/OMB)(Participants) | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 111 | 219 | 330 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | 25 Hydroxy-Vitamin D3 or [25 (OH) D3] | Total |
|---|---|---|---|
| United States | 111 | 219 | 330 |
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2013 to primary completion in Mar 2016, 30 months.
Results were first posted in May 2018, 2 years 2 months after primary completion.
Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 30 months is above that.
Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Cholecalciferol
Charles Drew University of Medicine and Science