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The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.
To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.
To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily 2000 IU vitamin D supplement | Experimental |
| |
| Daily Vitamin D supplement 400 IU | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2000 IU Vitamin D3 daily supplement | Dietary Supplement | 2000 IU vitamin D3 supplement to be taken once daily over 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma 25-OH D level | 3-4 months from baseline to post-testing |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | 3-4 months from baseline to post-testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanbin Dong, MD, PhD | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Prevention Institute at Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20660028 | Derived | Dong Y, Stallmann-Jorgensen IS, Pollock NK, Harris RA, Keeton D, Huang Y, Li K, Bassali R, Guo DH, Thomas J, Pierce GL, White J, Holick MF, Zhu H. A 16-week randomized clinical trial of 2000 international units daily vitamin D3 supplementation in black youth: 25-hydroxyvitamin D, adiposity, and arterial stiffness. J Clin Endocrinol Metab. 2010 Oct;95(10):4584-91. doi: 10.1210/jc.2010-0606. Epub 2010 Jul 21. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| 400 IU Vitamin D3 supplement | Dietary Supplement | 400 IU Vitamin D3 supplement to be taken daily over 4 months |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |