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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747447
First Posted: December 11, 2012
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Meryl LeBoff, Brigham and Women's Hospital
  Purpose
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,874 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 771 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 Dietary Supplement: Fish oil placebo Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
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 Meryl LeBoff, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Bone density [ Time Frame: 2 years ]
    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 ]
    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 ]
    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 ]
    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.


Enrollment: 771
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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
Dietary Supplement: 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 Dietary Supplement: 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 has enrolled a sub-cohort of 771 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 as well as trabecular bone score (TBS) at the spine; 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747447


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Meryl S LeBoff, M.D. Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
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 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2012
First Posted: December 11, 2012
Last Update Posted: November 10, 2017
Last Verified: November 2017

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