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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | VItamin D3 1,000 IU 1 x day, 8 weeks |
|
| Weekly High Dose | Experimental | Vitamin D3 50,000 IU 1x week, 8 weeks |
|
| Daily High Dose | Experimental | Vitamin D3 5,000 IU 1x day, 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) | Baseline to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M Coupey, MD | Children's Hospital at Montefiore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26707619 | Derived | Talib HJ, Ponnapakkam T, Gensure R, Cohen HW, Coupey SM. Treatment of Vitamin D Deficiency in Predominantly Hispanic and Black Adolescents: A Randomized Clinical Trial. J Pediatr. 2016 Mar;170:266-72.e1. doi: 10.1016/j.jpeds.2015.11.025. Epub 2015 Dec 18. |
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Of the 305 adolescents screened, only 203 met the inclusion criteria of being vitamin D deficient. Of the 203 adolescents identified with vitamin D deficiency, 20 were unable to be further contacted and randomized.
Patients were recruited aged 13-20 years from the Adolescent Medicine and Pediatric Endocrinology practices at Children's Hospital at Montefiore.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | VItamin D3 1,000 IU 1 x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
| FG001 | Weekly High Dose | Vitamin D3 50,000 IU 1x week, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
| FG002 | Daily High Dose | Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | VItamin D3 1,000 IU 1 x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
| BG001 | Weekly High Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) | Posted | Mean | Standard Deviation | ng/mL | Baseline to 3 months |
|
Duration of study (1 year)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | VItamin D3 1,000 IU 1 x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
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Substantial attrition rate is a limitation of this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hina Talib | Children's Hospital at Montefiore | 718-920-6781 | htalib@montefiore.org |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
Vitamin D3 50,000 IU
1x week, 8 weeks
Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
| BG002 | Daily High Dose | Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. |
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Weekly High Dose | Vitamin D3 50,000 IU 1x week, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. | 0 | 59 | 0 | 59 | 0 | 59 |
| EG002 | Daily High Dose | Vitamin D3 5,000 IU 1x day, 8 weeks Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. | 0 | 63 | 0 | 63 | 0 | 63 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |