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

Tufts University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01537809

1103016

3R01HL106160 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 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.

Enrollment: 691 patients

Sex: All

Ages: 9 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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691 participants in 3 patient groups

D3 600 IU/ daily

Active Comparator group

Description:

Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months.

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin D3

D3 1000 IU/ daily

Active Comparator group

Description:

Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months.

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin D3

D3: 2000 IU/daily

Active Comparator group

Description:

Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months.

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin D3