VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL) (NCT04573946) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL)
United States25,871 participantsStarted 2019-07-01
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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