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

October 9, 2012
April 17, 2014
July 2010
October 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01704859 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures
Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Fractures
  • Dietary Supplement: Vitamin D3 placebo
    Vitamin D placebo
  • Dietary Supplement: Fish oil placebo
    Fish oil 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]).
  • Dietary Supplement: Vitamin D3
    Vitamin D3 (cholecalciferol), 2000 IU per day.
    Other Name: cholecalciferol
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D3 placebo
    • Dietary Supplement: 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.

    Interventions:
    • Dietary Supplement: Vitamin D3 placebo
    • Drug: omega-3 fatty acids (fish oil)
  • 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

    Interventions:
    • Dietary Supplement: Fish oil placebo
    • Dietary Supplement: Vitamin D3
  • 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]).

    Interventions:
    • Drug: omega-3 fatty acids (fish oil)
    • Dietary Supplement: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25875
October 2017
October 2017   (final data collection date for primary outcome measure)

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

Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01704859
2010P002005, 1R01AR060574-01
Yes
Meryl LeBoff, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Meryl S LeBoff, M.D. Brigham and Women's Hospital
Brigham and Women's Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP