Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: Vitamin D3
- Registration Number
- NCT01537809
- Lead Sponsor
- Tufts University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 691
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D3 600 IU/ daily Vitamin D3 Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months. D3 1000 IU/ daily Vitamin D3 Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months. D3: 2000 IU/daily Vitamin D3 Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months.
- Primary Outcome Measures
Name Time Method Change in vitamin D levels over six month period Six months 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
- Secondary Outcome Measures
Name Time Method measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status 12 months Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months
Trial Locations
- Locations (1)
Tufts University
🇺🇸Boston, Massachusetts, United States