Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures

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:
NCT01704859
First received: October 9, 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 omega-3 fatty acids (Omacor® fish oil, 1 gram) 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 participants in VITAL and will examine whether vitamin D or fish oil: (1) will reduce incident total fractures and (2) will reduce incident hip and non-vertebral fractures.


Condition Intervention
Fractures
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
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 Fatty Acids (VITAL Trial): Effects on Fractures

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incident total fractures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine whether vitamin D and/or fish oil supplementation will reduce incident total fractures according to annual questionnaires, medical record review, and fracture adjudication.


Secondary Outcome Measures:
  • Incident hip and non-vertebral fractures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine whether vitamin D and/or fish oil supplementation will reduce incident hip and non-vertebral fractures, when examined separately and according to annual questionnaires, medical record review, and fracture adjudication.


Estimated Enrollment: 20000
Study Start Date: July 2010
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
Dietary Supplement: Fish oil placebo
Fish oil placebo
Active Comparator: Vitamin D placebo + 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 placebo.

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: vitamin D3. Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol

Dietary Supplement: 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

Dietary Supplement: vitamin D3. Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol

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]).

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 Fracture Study is an ancillary study of the parent VITAL trial (VITamin D and OmegA-3 TriaL). The study will require the adjudication of all self-reported incident fracture events among 10,000 men and 10,000 women. Findings from this ancillary study will inform clinical practice on the role(s) of vitamin D and/or omega-3 fatty acid supplements in fracture prevention. Because of the very high prevalence of low vitamin D levels and fractures in older adults, this trial will enable us to prove or disprove whether high-dose vitamin D and/or fish oil supplementation is effective in the primary prevention of age-related osteoporotic fractures in the U.S. These nutritional supplements may offer low-cost preventative interventions and reduce the burden of osteoporotic fractures with the potential for substantial individual and public health benefits.

  Eligibility

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

All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704859

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

Additional Information:
No publications provided

Responsible Party: Meryl LeBoff, Director of Skeletal Health and Osteoporosis Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01704859     History of Changes
Other Study ID Numbers: 2010P002005, 1R01AR060574-01
Study First Received: October 9, 2012
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
fracture

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

ClinicalTrials.gov processed this record on April 15, 2014