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

• ClinicalTrials.gov Identifier: NCT01704859
• Recruitment Status: Active, not recruiting
• First Posted: October 12, 2012
• Last Update Posted: July 18, 2022
• Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Information provided by (Responsible Party): Meryl LeBoff, Brigham and Women's Hospital

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	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.

Study Design

• 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

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 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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

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

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

More Information

Additional Information:

VITAL study website 

Publications:

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.

LeBoff MS, Chou SH, Murata EM, Donlon CM, Cook NR, Mora S, Lee IM, Kotler G, Bubes V, Buring JE, Manson JE. Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL). J Bone Miner Res. 2020 May;35(5):883-893. doi: 10.1002/jbmr.3958. Epub 2020 Jan 30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

LeBoff MS, Chou SH, Ratliff KA, Cook NR, Khurana B, Kim E, Cawthon PM, Bauer DC, Black D, Gallagher JC, Lee IM, Buring JE, Manson JE. Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults. N Engl J Med. 2022 Jul 28;387(4):299-309. doi: 10.1056/NEJMoa2202106.

Chou SH, Murata EM, Yu C, Danik J, Kotler G, Cook NR, Bubes V, Mora S, Chandler PD, Tobias DK, Copeland T, Buring JE, Manson JE, LeBoff MS. Effects of Vitamin D3 Supplementation on Body Composition in the VITamin D and OmegA-3 TriaL (VITAL). J Clin Endocrinol Metab. 2021 Apr 23;106(5):1377-1388. doi: 10.1210/clinem/dgaa981.

LeBoff MS, Murata EM, Cook NR, Cawthon P, Chou SH, Kotler G, Bubes V, Buring JE, Manson JE. VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population. J Clin Endocrinol Metab. 2020 Sep 1;105(9):2929-38. doi: 10.1210/clinem/dgaa311.

• 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 ( U.S. NIH Grant/Contract )
• First Posted: October 12, 2012
• Last Update Posted: July 18, 2022
• Last Verified: July 2022

• 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:

Fractures, Bone; Wounds and Injuries; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents