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Completed

NCT Number: NCT01537809

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

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.

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Key information

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

Subjects are told to take vitamin D daily for 6 months.

Primary outcomes

  1. Change in vitamin D levels over six month period

    Time frame: Six months

    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

Secondary outcomes

  1. measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status

    Time frame: 12 months

    Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Boston Children's Hospital
  • Boston University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Office of Dietary Supplements (ODS)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 23, 2012
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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