Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]
Overview
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.
Full Title of Study: “The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: December 2013
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.
Interventions
- Dietary Supplement: Vitamin D3
- Subjects are told to take vitamin D daily for 6 months.
- Dietary Supplement: Vitamin D3
- Subjects are asked to take vitamin D orally, daily for six months.
Arms, Groups and Cohorts
- Active Comparator: D3 600 IU/ daily
- Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months.
- Active Comparator: D3 1000 IU/ daily
- Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months.
- Active Comparator: D3: 2000 IU/daily
- Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months.
Clinical Trial Outcome Measures
Primary Measures
- Change in vitamin D levels over six month period
- Time Frame: 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 Measures
- measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status
- Time Frame: 12 months
- Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 9 Years
Maximum Age: 14 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Tufts University
- Collaborator
- Office of Dietary Supplements (ODS)
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Jennifer Sacheck, PhD, Principal Investigator, Tufts University
References
Sacheck J, Goodman E, Chui K, Chomitz V, Must A, Economos C. Vitamin D deficiency, adiposity, and cardiometabolic risk in urban schoolchildren. J Pediatr. 2011 Dec;159(6):945-50. doi: 10.1016/j.jpeds.2011.06.001. Epub 2011 Jul 23.
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