NCT04573946

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25,871 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Density
• Bone Health
• Fractures

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3 placebo	Vitamin D placebo
DIETARY_SUPPLEMENT	Fish oil placebo	Fish oil placebo
DRUG	Omega-3 fatty acids (fish oil)	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 \[DHA\]).
DIETARY_SUPPLEMENT	Vitamin D3	Vitamin D3 (cholecalciferol), 2000 IU per day. Other Names: cholecalciferol

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-07-21
• Completion: 2026-12-31
• First posted: 2020-10-05
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States