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

This study is ongoing, but not recruiting participants.
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: April 17, 2014
Last verified: April 2014
  Purpose

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 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.


Enrollment: 25875
Study Start Date: July 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 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

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 25,875 men and 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
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: 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: April 17, 2014
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 August 19, 2014