Bone Density, Bone Health, Fractures
Conditions
Keywords
Vitamin D, Vitamin K
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTVitamin D3 placebo
Vitamin D placebo
DIETARY_SUPPLEMENTFish oil placebo
Fish oil placebo
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 \[DHA\]).
DIETARY_SUPPLEMENTVitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day. Other Names: cholecalciferol
Sponsors
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Fractures | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Areal Bone Density | 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. |
| Change in Volumetric Bone Mineral Density | 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. |
| Change in Cortical Thickness | 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. |
| Change in Bone Strength | 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. |
| Change in Trabecular Bone Score | 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. |
| Concentration of Urine Calcium | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMeryl S LeBoff, M.D.
Brigham and Women's Hospital
Outcome results
None listed