VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Meryl LeBoff, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01747447
First received: December 7, 2012
Last updated: July 29, 2013
Last verified: July 2013

December 7, 2012
July 29, 2013
August 2012
June 2016   (final data collection date for primary outcome measure)
  • Bone density [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine whether vitamin D and/or fish oil supplementation produces small increases or reduces bone loss in spine, hip, and total body areal bone density,as assessed by DXA.
  • Bone Turnover [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine whether vitamin D and/or fish oil supplementation reduces bone turnover, as assessed biomarkers of bone resorption and bone formation.
Same as current
Complete list of historical versions of study NCT01747447 on ClinicalTrials.gov Archive Site
Bone Structure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine whether vitamin D and/or fish oil supplementation results in changes in bone structure.
Same as current
Body Composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine whether vitamin D and/or fish oil supplementation results in changes in body composition as assessed by DXA: total body fat and lean mass, and fat mass index and lean mass index, regional fat and lean mass and derived ratios.
Same as current
 
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among a sub-cohort of 600 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.

The VITAL: Effects on Bone Structure and Architecture is an ancillary study of the parent VITAL. This study will enroll a sub-cohort of 600 VITAL participants at the NIH-sponsored Harvard Catalyst Clinical and Translational Science Center (CTSC). The following measurements will be performed at baseline and 2 years post-randomization to determine whether high-dose vitamin D supplementation vs. placebo: 1) Produces small increases or reduces bone loss in spine, hip, and total body areal bone density as assessed by DXA; 2) reduces bone turnover as assessed by biomarkers of bone resorption and formation; 3) Improves measures of bone structure at the distal radius and tibia; 4) results in changes in body composition assessed by DXA. Parallel assessments of the effects of omega-3 fatty acids will be performed. This study may elucidate the mechanisms through which high-dose vitamin D may prevent age-related fractures and provide new insights into the role of vitamin D on skeletal health and body composition.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Bone Density
  • Body Composition
  • Bone Health
  • Dietary Supplement: Vitamin D3 placebo
    Vitamin D placebo
  • Drug: Fish oil placebo
    Fish oil placebo
  • Drug: omega-3 fatty acids (fish oil)
    Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
  • Dietary Supplement: Vitamin D3
    Vitamin D3 (cholecalciferol), 2000 IU per day.
    Other Name: cholecalciferol
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D3 placebo
    • Drug: Fish oil placebo
  • Active Comparator: Vitamin D placebo + fish oil
    Interventions:
    • Dietary Supplement: Vitamin D3 placebo
    • Drug: omega-3 fatty acids (fish oil)
  • Active Comparator: Vitamin D + fish oil placebo
    Interventions:
    • Drug: Fish oil placebo
    • Dietary Supplement: Vitamin D3
  • Active Comparator: Vitamin D + fish oil
    Interventions:
    • Drug: omega-3 fatty acids (fish oil)
    • Dietary Supplement: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
600
June 2016
June 2016   (final data collection date for primary outcome measure)

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:

  • Those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this study.
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01747447
2012P000560, 5R01AR060574-03
Yes
Meryl LeBoff, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Meryl S LeBoff, M.D. Brigham and Women's Hospital
Brigham and Women's Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP