VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)

NCT01747447 | Completed Results DMC

• 3 other identifiers: 2012P0005601R01AR059775-01A15R01AR060574-03
• Study Type: interventional
• Target: 771
• 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 fish oil (1 gram of omega-3 fatty acids) 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 a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.

Conditions

Bone Density; Body Composition; Bone Health

Outcome Measures

Primary Outcomes (3)

• Change in Bone Density

  To determine whether vitamin D and/or omega-3 supplementation produces small increases or reduces bone loss in spine, hip, and total body areal bone density, as assessed by DXA. Reported values are rounded up.

  2 years

• Bone Turnover P1NP

  To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone formation (propeptide of type 1 collagen \[P1NP\]).

  2 years

• Bone Turnover Beta Crosslaps

  To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone resorption (beta crosslaps).

  2 years

Secondary Outcomes (1)

• Change in Bone Structure

  2 years

Other Outcomes (1)

• Body Composition

  2 years

Study Arms (4)

Vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR

Daily vitamin D placebo and daily fish oil placebo

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

Vitamin D placebo + fish oil

ACTIVE COMPARATOR

Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

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

Vitamin D + fish oil placebo

ACTIVE COMPARATOR

Daily vitamin D (2,000 IU/d) and daily fish oil placebo

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

Vitamin D + fish oil

ACTIVE COMPARATOR

Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

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

Interventions

Vitamin D3 placebo DIETARY_SUPPLEMENT

Vitamin D placebo

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

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) DIETARY_SUPPLEMENT

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 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+)

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study: * Those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this 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 (6)

• 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

• Donlon CM, LeBoff MS, Chou SH, Cook NR, Copeland T, Buring JE, Bubes V, Kotler G, Manson JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture. Contemp Clin Trials. 2018 Apr;67:56-67. doi: 10.1016/j.cct.2018.02.003. Epub 2018 Feb 23.

  PMID: 29408561 BACKGROUND

• Goldman AL, Donlon CM, Cook NR, Manson JE, Buring JE, Copeland T, Yu CY, LeBoff MS. VITamin D and OmegA-3 TriaL (VITAL) bone health ancillary study: clinical factors associated with trabecular bone score in women and men. Osteoporos Int. 2018 Nov;29(11):2505-2515. doi: 10.1007/s00198-018-4633-3. Epub 2018 Jul 18.

  PMID: 30022253 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

• 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

Interventions

Fatty Acids, Omega-3; Fish Oils; Cholecalciferol

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

Limitations and Caveats

Timeline limited to 2 years of follow-up; results not adjusted for multiple hypothesis testing, so findings from the secondary and subgroup analyses are exploratory; results are not generalizable to younger individuals or adults with osteoporosis.

Results Point of Contact

• Title: Meryl S LeBoff, M.D.
• Organization: Brigham and Women's Hospital

vitalstudy@partners.org

1-800-388-3963

Study Officials

• Meryl S LeBoff, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: December 7, 2012
• First Posted: December 11, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: August 2, 2023
• Last Updated: April 28, 2026
• Results First Posted: March 29, 2021

Record last verified: 2026-04

Locations

US (1)