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

This study has been completed.
Sponsor:
Collaborators:
Boston University
Children's Hospital Boston
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01537809
First received: February 17, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
Vitamin D Deficiency
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Change in vitamin D levels over six month period [ Time Frame: Six months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Baseline cardiometabolic risk factors will be compared at 3, 6 and 12 months


Enrollment: 691
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537809

Locations
United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Boston University
Children's Hospital Boston
Investigators
Principal Investigator: Jennifer Sacheck, PhD Tufts University
  More Information

Publications:
Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01537809     History of Changes
Other Study ID Numbers: 1103016, 3R01HL106160, 3R01HL106160
Study First Received: February 17, 2012
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
Vitamin D
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Blood lipids

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014