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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