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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25871 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Bone Density Bone Health Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vitamin D placebo + fish oil placebo

Group Type PLACEBO_COMPARATOR

Vitamin D3 placebo

Intervention Type DIETARY_SUPPLEMENT

Vitamin D placebo

Fish oil placebo

Intervention Type DIETARY_SUPPLEMENT

Fish oil placebo

Vitamin D placebo + fish oil

Group Type ACTIVE_COMPARATOR

Vitamin D3 placebo

Intervention Type DIETARY_SUPPLEMENT

Vitamin D placebo

Omega-3 fatty acids (fish oil)

Intervention Type 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 placebo

Group Type ACTIVE_COMPARATOR

Fish oil placebo

Intervention Type DIETARY_SUPPLEMENT

Fish oil placebo

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day.

Other Names: cholecalciferol

Vitamin D + fish oil

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acids (fish oil)

Intervention Type 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 D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day.

Other Names: cholecalciferol

Interventions

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Vitamin D3 placebo

Vitamin D placebo

Intervention Type DIETARY_SUPPLEMENT

Fish oil placebo

Intervention Type DIETARY_SUPPLEMENT

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 \[DHA\]).

Intervention Type DRUG

Vitamin D3

Vitamin D3 (cholecalciferol), 2000 IU per day.

Other Names: cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\- 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:

\- 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No