Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]

Study Overview
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Brief Summary
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The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.

Detailed Description
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Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.

Official Title
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The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects in 4th-8th grade Subjects must attend school where study is being conducted Subject and parent/guardian must give assent/consent to participate in study Related Requirements Subjects must complete all study visits (baseline, 3,6 and 12 months) Subjects must agree to be blinded Exclusion Criteria: Subjects taking glucocorticoids Subjects not in 4th-8th grade Clinical diagnosis of Cystic Fibrosis Clinical diagnosis of Kidney disease Subjects currently taking a vitamin D supplement of >1000 IU/day Subjects diagnosed with Irritable Bowel Syndrome (IBS) Clinical diagnosis of AIDS Clinical diagnosis of Sarcoidosis Clinical diagnosis of Epilepsy

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D3 600 IU/ daily<br>Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months. | Dietary Supplement: Vitamin D3<br>* Subjects are told to take vitamin D daily for 6 months.<br>Dietary Supplement: Vitamin D3<br>* Subjects are asked to take vitamin D orally, daily for six months.<br>|
| Active Comparator: D3 1000 IU/ daily<br>Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months. | Dietary Supplement: Vitamin D3<br>* Subjects are told to take vitamin D daily for 6 months.<br>Dietary Supplement: Vitamin D3<br>* Subjects are asked to take vitamin D orally, daily for six months.<br>|
| Active Comparator: D3: 2000 IU/daily<br>Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months. | Dietary Supplement: Vitamin D3<br>* Subjects are told to take vitamin D daily for 6 months.<br>Dietary Supplement: Vitamin D3<br>* Subjects are asked to take vitamin D orally, daily for six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vitamin D levels over six month period | Subjects will be randomized to receive one of three doses of vitamin D3. Baseline serum 25(OH)D levels will be compared to serum 25(OH)D at 3 and 6 months. Safety Issue?: (FDAAA) No | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status | Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Vitamin D Deficiency, Avitaminosis, Deficiency Diseases, Blood lipids