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

Mass General Brigham

Status: Active, not recruiting

Conditions: Bone Health; Fractures; Bone Density

Treatments: Dietary Supplement: Fish oil placebo; Dietary Supplement: Vitamin D3; Drug: Omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04573946

2R01AR059775-06A1 (U.S. NIH Grant/Contract)

5R01AR060574-03 (U.S. NIH Grant/Contract)

2012P000560-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25,871 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

- 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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25,871 participants in 4 patient groups, including a placebo group

Vitamin D placebo + fish oil placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Vitamin D3 placebo

Dietary Supplement: Fish oil placebo

Vitamin D placebo + fish oil

Active Comparator group

Treatment:

Dietary Supplement: Vitamin D3 placebo

Drug: Omega-3 fatty acids (fish oil)

Vitamin D + fish oil placebo

Active Comparator group

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Fish oil placebo

Vitamin D + fish oil

Active Comparator group

Treatment:

Drug: Omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3