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VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL) | Clinical Trials | Clareo Health

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

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

NCT04573946•Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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:

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

July 1, 2019

Primary Completion Date

July 21, 2023

Completion Date

December 31, 2026

Last Updated

January 30, 2026

Enrollment

25,871

ACTUAL participants

Conditions

Bone DensityBone HealthFractures

Interventions

Vitamin D3 placebo

DIETARY_SUPPLEMENT

Fish oil placebo

DIETARY_SUPPLEMENT

Omega-3 fatty acids (fish oil)

DRUG

Vitamin D3

DIETARY_SUPPLEMENT

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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: March 29, 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

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