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

NCT01704859 | Completed DMC

• 2 other identifiers: 2010P0020051R01AR070854-01A1
• Study Type: interventional
• Target: 25,871
• Locations: 1 country
• Sites: 1

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

Conditions

Fractures

Keywords

fracture

Outcome Measures

Primary Outcomes (1)

• Incident total, non-vertebral, and hip fractures

  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.

  5 years

Secondary Outcomes (1)

• Incident total, non-vertebral, and hip fractures

  5 years

Study Arms (4)

Vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo

Vitamin D placebo + fish oil

ACTIVE COMPARATOR

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

Vitamin D + fish oil placebo

ACTIVE COMPARATOR

Dietary Supplement: Fish oil placebo; Dietary Supplement: Vitamin D3

Vitamin D + fish oil

ACTIVE COMPARATOR

Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3

Interventions

Fish oil placebo DIETARY_SUPPLEMENT

Fish oil placebo

Vitamin D + fish oil placebo; Vitamin D placebo + fish oil placebo

omega-3 fatty acids (fish oil) DRUG

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 \[DHA\]).

Vitamin D + fish oil; Vitamin D placebo + fish oil

Vitamin D3 placebo DIETARY_SUPPLEMENT

Vitamin D placebo

Vitamin D placebo + fish oil; Vitamin D placebo + fish oil placebo

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day.

Also known as: cholecalciferol

Vitamin D + fish oil; Vitamin D + fish oil placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• 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.

  PMID: 25623291 BACKGROUND

• 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.

  PMID: 31923341 BACKGROUND

• 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.

  PMID: 35939577 BACKGROUND

• 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.

  PMID: 33513226 DERIVED

• 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.

  PMID: 32492153 DERIVED

Related Links

• VITAL study website

MeSH Terms

Conditions

Fractures, Bone

Interventions

Fatty Acids, Omega-3; Fish Oils; Cholecalciferol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids

Study Officials

• Meryl S LeBoff, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Skeletal Health and Osteoporosis Center

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: June 1, 2018
• Primary Completion: March 31, 2022
• Study Completion: November 23, 2022
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)