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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fractures, Bone Density, Bone Health

Intervention / Treatment
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* Dietary Supplement: Vitamin D3 placebo
* Dietary Supplement: Fish oil placebo
* Drug: Omega-3 fatty acids (fish oil)
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vitamin D placebo + fish oil placebo<br> | Dietary Supplement: Vitamin D3 placebo<br>* Vitamin D placebo<br>Dietary Supplement: Fish oil placebo<br>* Fish oil placebo<br>|
| Active Comparator: Vitamin D placebo + fish oil<br> | Dietary Supplement: Vitamin D3 placebo<br>* Vitamin D placebo<br>Drug: Omega-3 fatty acids (fish oil)<br>* 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]).<br>|
| Active Comparator: Vitamin D + fish oil placebo<br> | Dietary Supplement: Fish oil placebo<br>* Fish oil placebo<br>Dietary Supplement: Vitamin D3<br>* Vitamin D3 (cholecalciferol), 2000 IU per day. Other Names: cholecalciferol<br>|
| Active Comparator: Vitamin D + fish oil<br> | Drug: Omega-3 fatty acids (fish oil)<br>* 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]).<br>Dietary Supplement: Vitamin D3<br>* Vitamin D3 (cholecalciferol), 2000 IU per day. Other Names: cholecalciferol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Fractures | The effect of low vitamin K status (with or without vitamin D supplementation) on the number of new total, non-vertebral and hip fractures. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Areal Bone Density | 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 years | 
| Change in Volumetric Bone Mineral Density | 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. | 2 years | 
| Change in Cortical Thickness | 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. | 2 years | 
| Change in Bone Strength | 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. | 2 years | 
| Change in Trabecular Bone Score | 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. | 2 years | 
| Concentration of Urine Calcium | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin K, Vitamin D