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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014