VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25,871
- 试验地点
- 1
- 主要终点
- Number of Fractures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- 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
研究组 & 干预措施
Vitamin D + fish oil
干预措施: Omega-3 fatty acids (fish oil) (Drug)
Vitamin D placebo + fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D + fish oil
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D placebo + fish oil placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D + fish oil placebo
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D placebo + fish oil
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D placebo + fish oil
干预措施: Omega-3 fatty acids (fish oil) (Drug)
Vitamin D + fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
结局指标
主要结局
Number of Fractures
时间窗: 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.
次要结局
- Change in Bone Strength(2 years)
- Change in Trabecular Bone Score(2 years)
- Change in Volumetric Bone Mineral Density(2 years)
- Change in Areal Bone Density(2 years)
- Change in Cortical Thickness(2 years)
- Concentration of Urine Calcium(2 years)
研究者
Meryl LeBoff
Director of Skeletal Health and Osteoporosis Center
Brigham and Women's Hospital