A Phase 4 interventional study of Vitamin D3 in Vitamin D Deficiency, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 13 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly Hispanic and black adolescents with vitamin D deficiency [25(OH)D level \<20 ng/ml] by assessing change in 25(OH)D levels before and after 8 weeks of treatment.
To compare the effects of vitamin D repletion [25(OH)D level >20 ng/mL] on selected musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black adolescents with vitamin D deficiency [25(OH)D level \< 20 ng/mL].
Hypothesis 1: Increase in vitamin D level will be associated with improvement in musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.
Vitamin D is an essential nutrient and pro-hormone that has garnered widespread attention over the past decade for both its known and theorized health benefits. Patients, clinicians and researchers have all been alerted to the increasing prevalence of vitamin D deficiency (defined as level of 25(OH)D \<20 ng/mL) and the significance of the extra-skeletal health effects of vitamin D. Aside from the skeletal impacts of Vitamin D, there has been recent evidence about potential health benefits of vitamin D related to the multiple extra-skeletal roles of this hormone. In fact, vitamin D receptors are found in many organs including brain, heart, skin, small intestine, gonads, prostate and breast as well in almost all nucleated cells including osteoblasts, activated T and B-lymphocytes, and B islet cells. Studies in children and adolescents as well as in adults show associations of vitamin D deficiency with cardiovascular risk factors, musculoskeletal health, asthma, and autoimmune diseases.
While Vitamin D deficiency is quite prevalent, adolescents who are obese or who are darker skinned are consistently shown to have higher rates of vitamin D deficiency than lean and lighter skinned adolescents. Treatment of vitamin D deficiency and maintenance of sufficient levels in adolescents are largely under-studied leaving patients and clinicians without clear evidence-based guidelines to follow.
The goal of this study is to compare the efficacy of different treatment regimens for vitamin D deficiency in our population of predominantly minority adolescents and to examine the effect of correction of vitamin D deficiency on selected extra-skeletal targets of vitamin D action including musculoskeletal, cardiometabolic, and immune function.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 183 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
VItamin D3 1,000 IU 1 x day, 8 weeks
Drug: Vitamin D3
Vitamin D3 50,000 IU 1x week, 8 weeks
Drug: Vitamin D3
Vitamin D3 5,000 IU 1x day, 8 weeks
Drug: Vitamin D3
Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Also known as: cholecalciferol
Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)
Time frame: Baseline to 3 months
Patients were recruited aged 13-20 years from the Adolescent Medicine and Pediatric Endocrinology practices at Children's Hospital at Montefiore.
| Milestone | Low Dose | Weekly High Dose | Daily High Dose |
|---|---|---|---|
| Started | 61 | 59 | 63 |
| Completed | 42 | 39 | 41 |
| Not completed | 19 | 20 | 22 |
| Withdrew: Lost to follow-up | 19 | 20 | 22 |
| ng/mL | Low Dose | Weekly High Dose | Daily High Dose |
|---|---|---|---|
| Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) | 6.2 ± 6.5 | 24.9 ± 15.1 | 21 ± 15.2 |
Collected over Duration of study (1 year). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| Weekly High Dose | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Daily High Dose | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) |
| Age, Continuous(years) | Low Dose | Weekly High Dose | Daily High Dose | Total |
|---|---|---|---|---|
| Mean | 16.8 ± 2.1 | 16.5 ± 2.4 | 16.6 ± 2.1 | 16.6 ± 2.2 |
| Sex: Female, Male(Participants) | Low Dose | Weekly High Dose | Daily High Dose | Total |
|---|---|---|---|---|
| Female | 45 | 45 | 46 | 136 |
| Male | 16 | 14 | 17 | 47 |
This study is completed, as verified in Sep 2018. 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.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Montefiore Medical Center