NCT01537809

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 691 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 9 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-02-23
• Last updated: 2013-12-13

Locations

1 site across 1 country: United States