An interventional study of Vitamin D3 and Vitamin D3 in Vitamin D Deficiency, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-13.
Sponsored by Tufts University · Not applicable, Interventional, and Prevention
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.
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.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 691 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months.
Dietary Supplement: Vitamin D3
Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months.
Dietary Supplement: Vitamin D3
Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months.
Dietary Supplement: Vitamin D3
Subjects are told to take vitamin D daily for 6 months.
Subjects are asked to take vitamin D orally, daily for six months.
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
Time frame: Six months
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
Time frame: 12 months
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Tufts University