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

Completed · Not applicable

Conditions studied: Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT01537809

Run by

Tufts University

People needed

691

Starts

2011-06-01

Expected to finish

2013-12-01

Last updated by the study team

2013-12-13

Who can join

Age: 9 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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