VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL)

NCT04573946 | Active Not Recruiting DMC

• 3 other identifiers: 2012P000560-12R01AR059775-06A15R01AR060574-03
• Study Type: interventional
• Target: 25,871
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D supplements are widely promoted for bone health. Both vitamin D and vitamin K are important for deposition of calcium in bone, but little is known about the relationship of vitamin K status and bone health.

Conditions

Bone Density; Bone Health; Fractures

Keywords

Vitamin D; Vitamin K

Outcome Measures

Primary Outcomes (1)

• Number of Fractures

  The effect of low vitamin K status (with or without vitamin D supplementation) on the number of new total, non-vertebral and hip fractures.

  2 years

Secondary Outcomes (6)

• Change in Areal Bone Density

  2 years

• Change in Volumetric Bone Mineral Density

  2 years

• Change in Cortical Thickness

  2 years

• Change in Bone Strength

  2 years

• Change in Trabecular Bone Score

  2 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

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) 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 DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day. Other Names: cholecalciferol

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants in VITAL (NCT 01169259) study who met the following criteria of the parent trial are eligible to participate in this ancillary study:
• be men aged 50 years and older or women aged 55 years and older
• have no history of cardiovascular disease or cancer (excluding non-melanoma skin cancer)
• have none of the following: allergy to soy or fish, hypercalcemia, renal failure or dialysis, severe liver disease, hypo- or hyperparathyroidism, sarcoidosis or other granulomatous diseases, or any other serious illnesses
• consume ≤ 1200 mg/d of calcium for the duration of the trial
• consume ≤ 800 IU of vitamin D for duration of the trial
• refrain from taking fish oil supplements for the duration of the trial

You may not qualify if:

• \- For aims 2 and 3, 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

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 (4)

• 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

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
• 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: September 1, 2020
• First Posted: October 5, 2020
• Study Start: July 1, 2019
• Primary Completion: July 21, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)