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Active Not RecruitingNANCT04573946

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

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 ...

Lead sponsor: Brigham and Women's Hospital•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Brigham and Women's Hospital

Collaborators

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

The goal of VITAL: Interrelationship of Vitamin D and Vitamin K on Bone is to test whether vitamin K status is associated with incident fractures in a case-cohort design or modifies the randomized effects of vitamin D supplementation vs. placebo on 2-year changes in bone density and structure outcomes.

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Inclusion:
•\- 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
•Exclusion:

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 30, 2026Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment25,871

Start dateJul 2019

Last updatedJan 30, 2026

Condition

Bone Density Bone Health Fractures

Locations shown

Brigham and Women's Hospital

Boston, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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