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NCT Number: NCT04573946

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bone Density Bone Health Fractures Fractures, Bone Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3 placebo

Dietary Supplement

Vitamin D placebo

Fish oil placebo

Dietary Supplement

Fish oil placebo

omega-3 fatty acids (fish oil)

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

Dietary Supplement

Vitamin D3 (cholecalciferol), 2000 IU per day.

Other Names: cholecalciferol

Primary outcomes

  1. Number of Fractures

    Time frame: 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 outcomes

  1. Change in Areal Bone Density

    Time frame: 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.

  2. Change in Volumetric Bone Mineral Density

    Time frame: 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.

  3. Change in Cortical Thickness

    Time frame: 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.

  4. Change in Bone Strength

    Time frame: 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.

  5. Change in Trabecular Bone Score

    Time frame: 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.

  6. Concentration of Urine Calcium

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Oct 5, 2020
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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