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

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.

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.

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