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

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT01537809

Collaborator

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

691

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

691 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: D3 600 IU/ daily Subjects randomized to 600 IU/day of vitamin D3 taken orally for six months.	Dietary Supplement: Vitamin D3 Subjects are told to take vitamin D daily for 6 months. Dietary Supplement: Vitamin D3 Subjects are asked to take vitamin D orally, daily for six months.
Active Comparator: D3 1000 IU/ daily Subjects randomized to 1000 IU/day of vitamin D3 taken orally for six months.	Dietary Supplement: Vitamin D3 Subjects are told to take vitamin D daily for 6 months. Dietary Supplement: Vitamin D3 Subjects are asked to take vitamin D orally, daily for six months.
Active Comparator: D3: 2000 IU/daily Subjects randomized to 2000 IU/day of vitamin D3 taken orally for six months.	Dietary Supplement: Vitamin D3 Subjects are told to take vitamin D daily for 6 months. Dietary Supplement: Vitamin D3 Subjects are asked to take vitamin D orally, daily for six months.

Arm

Intervention/Treatment

Active Comparator: D3 600 IU/ daily

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