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VITamin D and OmegA-3 TriaL (VITAL): Fractures, Vitamin D and Genetic Markers

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ClinicalTrials.gov Identifier: NCT01704859
Recruitment Status : Active, not recruiting
First Posted : October 12, 2012
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Meryl LeBoff, Brigham and Women's Hospital

Brief Summary:
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 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 (1) whether vitamin D reduces incident total, non-vertebral fractures, and hip fractures and (2) whether this reduction is modified by vitamin D levels

Condition or disease Intervention/treatment Phase
Fractures Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 Not Applicable

Detailed Description:
The VITAL: Vitamin D, Fractures, and Genetic Markers 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 25,871 men and women. Findings from this ancillary study will inform clinical practice on the role(s) of vitamin D supplements in fracture prevention. This proposal will generate important positive or informative negative results about effects of supplemental vitamin D3 alone on fracture risk, while also elucidating the relative importance of vitamin D biomarkers and genetic variations in vitamin D-related pathways on bone. Findings from the proposed ancillary study have the potential for major clinical as well as public health impact for both men and women in the U.S.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25871 participants
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 (VITAL): Fractures, Vitamin D and Genetic Markers
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incident total, non-vertebral, and hip fractures [ Time Frame: 5 years ]
    To determine whether vitamin D supplementation will reduce incident total, non-vertebral, and hip fractures according to annual questionnaires, medical record review, and fracture adjudication.


Secondary Outcome Measures :
  1. Incident total, non-vertebral, and hip fractures [ Time Frame: 5 years ]
    To determine whether baseline vitamin D levels and genetic variation in vitamin D-related pathways modify effects of vitamin D supplements on fractures.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

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): NCT01704859


Locations
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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
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Principal Investigator: Meryl S LeBoff, M.D. Brigham and Women's Hospital

Additional Information:
Publications:
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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
1R01AR070854-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meryl LeBoff, Brigham and Women's Hospital:
fracture
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents