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

Not Applicable

Active, not recruiting

• Conditions: Bone Density; Fractures; Bone Health
• Interventions: Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo; Drug: Omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3

• Registration Number: NCT04573946
• Lead Sponsor: Brigham and Women's Hospital

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.

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-10-05
• Primary Completion: 2023-07-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-03-25
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25871

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin D placebo + fish oil placebo	Vitamin D3 placebo	-
Vitamin D placebo + fish oil placebo	Fish oil placebo	-
Vitamin D placebo + fish oil	Vitamin D3 placebo	-
Vitamin D placebo + fish oil	Omega-3 fatty acids (fish oil)	-
Vitamin D + fish oil placebo	Fish oil placebo	-
Vitamin D + fish oil placebo	Vitamin D3	-
Vitamin D + fish oil	Omega-3 fatty acids (fish oil)	-
Vitamin D + fish oil	Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
Number of Fractures	2 years	The effect of low vitamin K status (with or without vitamin D supplementation) on the number of new total, non-vertebral and hip fractures.

Secondary Outcome Measures

Name	Time	Method
Change in Bone Strength	2 years	The effect of low vitamin K status (with or without vitamin D supplementation) on changes in bone strength measures assessed by peripheral quantitative computed tomography (pQCT) between baseline and two years post-randomization.
Change in Trabecular Bone Score	2 years	The effect of low vitamin K status (with or without vitamin D supplementation) on changes in trabecular bone score between baseline and two years post-randomization.
Change in Volumetric Bone Mineral Density	2 years	The effect of low vitamin K status (with or without vitamin D supplementation) on changes in total, trabecular and cortical volumetric bone mineral density (vBMD) between baseline and two years post-randomization.
Change in Areal Bone Density	2 years	The effect of low vitamin K status (with or without vitamin D supplementation) on changes in areal bone density at the spine and hip between baseline and two years post-randomization.
Change in Cortical Thickness	2 years	The effect of low vitamin K status (with or without vitamin D supplementation) on changes in cortical thickness assessed by peripheral quantitative computed tomography (pQCT) between baseline and two years post-randomization.
Concentration of Urine Calcium	2 years	The effect of low vitamin K status (with or without vitamin D supplementation) on change in urine calcium excretion between baseline and two years post-randomization.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States