Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 9 - 14 |
| Updated: | 5/27/2013 |
| Start Date: | June 2011 |
| End Date: | November 2014 |
| Contact: | Jennifer Sacheck, PhD |
| Email: | jennifer.sacheck@tufts.edu |
| Phone: | 617-636-3917 |
The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren
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.
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
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