Overview

This trial is active, not recruiting.

Conditions bone density, body composition, bone health
Treatments vitamin d3 placebo, fish oil placebo, omega-3 fatty acids (fish oil), vitamin d3
Sponsor Brigham and Women's Hospital
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date August 2012
End date October 2017
Trial size 778 participants
Trial identifier NCT01747447, 2012P000560, 5R01AR060574-03

Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,875 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 770 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
vitamin d3 placebo
Vitamin D placebo
fish oil placebo
Fish oil placebo
(Active Comparator)
vitamin d3 placebo
Vitamin D placebo
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)
fish oil placebo
Fish oil placebo
vitamin d3 cholecalciferol
Vitamin D3 (cholecalciferol), 2000 IU per day.
(Active Comparator)
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]).
vitamin d3 cholecalciferol
Vitamin D3 (cholecalciferol), 2000 IU per day.

Primary Outcomes

Measure
Bone density
time frame: 2 years
Bone Turnover
time frame: 2 years

Secondary Outcomes

Measure
Bone Structure
time frame: 2 years

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

Official title VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
Principal investigator Meryl S LeBoff, M.D.
Description The VITAL: Effects on Bone Structure and Architecture is an ancillary study of the parent VITAL. This study has enrolled a sub-cohort of 770 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 dual x-ray absorptiometry (DXA); 2) reduces bone turnover as assessed by biomarkers of bone resorption and formation; 3) improves (a) volumetric bone mineral density (vBMD) and measures of bone structure as assessed by peripheral quantitative computed tomography (pQCT) and (b) bone microarchitecture as assessed by high resolution pQCT (HR-pQCT) at the distal radius and tibia; and 4) results in changes in body composition as 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.