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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704859
First Posted: October 12, 2012
Last Update Posted: March 16, 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
October 9, 2012
October 12, 2012
March 16, 2017
July 2010
December 2017   (Final data collection date for primary outcome measure)
Incident total fractures [ Time Frame: 2 years ]
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 ]
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 25,874 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 will (1) reduce incident total fractures and (2) 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 25,874 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
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
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
    Interventions:
    • Dietary Supplement: Vitamin D3 placebo
    • Drug: omega-3 fatty acids (fish oil)
  • Active Comparator: Vitamin D + fish oil placebo
    Interventions:
    • Dietary Supplement: Fish oil placebo
    • Dietary Supplement: Vitamin D3
  • Active Comparator: Vitamin D + fish oil
    Interventions:
    • Drug: omega-3 fatty acids (fish oil)
    • Dietary Supplement: Vitamin D3
LeBoff MS, Yue AY, Copeland T, Cook NR, Buring JE, Manson JE. VITAL-Bone Health: rationale and design of two ancillary studies evaluating the effects of vitamin D and/or omega-3 fatty acid supplements on incident fractures and bone health outcomes in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2015 Mar;41:259-68. doi: 10.1016/j.cct.2015.01.007. Epub 2015 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25874
December 2017
December 2017   (Final data collection date for primary outcome measure)
All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01704859
2010P002005
1R01AR060574-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
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
March 2017

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