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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537809
• Other study ID #: 1103016
• Secondary ID: 3R01HL106160
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: December 12, 2013
• Start date: June 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Subjects are told to take vitamin D daily for 6 months.
• Vitamin D3
Subjects are asked to take vitamin D orally, daily for six months.

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sacheck J, Goodman E, Chui K, Chomitz V, Must A, Economos C. Vitamin D deficiency, adiposity, and cardiometabolic risk in urban schoolchildren. J Pediatr. 2011 Dec;159(6):945-50. doi: 10.1016/j.jpeds.2011.06.001. Epub 2011 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vitamin D levels over six month period	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	Six months	No
Secondary	measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status	Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months	12 months	No