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
  Purpose

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.


Condition Intervention
Bone Density
Body Composition
Bone Health
Dietary Supplement: Vitamin D3 placebo
Drug: Fish oil placebo
Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 600
Study Start Date: August 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vitamin D placebo + fish oil placebo Dietary Supplement: Vitamin D3 placebo
Vitamin D placebo
Drug: Fish oil placebo
Fish oil placebo
Active Comparator: Vitamin D placebo + fish oil Dietary Supplement: Vitamin D3 placebo
Vitamin D 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]).
Active Comparator: Vitamin D + fish oil placebo Drug: Fish oil placebo
Fish oil placebo
Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol
Active Comparator: Vitamin D + fish oil 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01747447

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Meryl S LeBoff, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Meryl LeBoff, Director of Skeletal Health and Osteoporosis Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01747447     History of Changes
Other Study ID Numbers: 2012P000560, 5R01AR060574-03
Study First Received: December 7, 2012
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014