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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01704859

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

25,871

Enrollment

Location

Arms

Anticipated Duration (Months)

431.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2018

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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 Names: 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 Names: cholecalciferol

Outcome Measures

Primary Outcome Measures

Incident total, non-vertebral, and hip fractures [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

Incident total, non-vertebral, and hip fractures [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

All participants from the VITAL parent study (NCT01169259) were enrolled in this ancillary study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

VITAL study website

Publications

Responsible Party:

Meryl LeBoff, Director of Skeletal Health and Osteoporosis Center, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT01704859

Other Study ID Numbers:

2010P002005
1R01AR070854-01A1

First Posted:

Oct 12, 2012

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Meryl LeBoff, Director of Skeletal Health and Osteoporosis Center, Brigham and Women's Hospital

fracture

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022