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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01537809
Enrollment
691
Registered
2012-02-23
Start date
2011-06-30
Completion date
2013-12-31
Last updated
2013-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D, Vitamin D Deficiency, Avitaminosis, Deficiency Diseases, Blood lipids

Brief summary

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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

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

Sponsors

Office of Dietary Supplements (ODS)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Boston University
CollaboratorOTHER
Boston Children's Hospital
CollaboratorOTHER
Tufts University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in vitamin D levels over six month periodSix monthsSubjects 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

MeasureTime frameDescription
measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status12 monthsBaseline cardiometabolic risk factors will be compared at 3, 6 and 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026