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

December 12, 2013 updated by: Tufts University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

691

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Collaborators

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

Investigators

  • Principal Investigator: Jennifer Sacheck, PhD, Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

February 17, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1103016
  • 3R01HL106160 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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