Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25,871
- 试验地点
- 1
- 主要终点
- Number of Participants With New Heart Failure Hospitalization
研究概览
简要总结
This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.
详细描述
For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.
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
- Quadruple (Participant, Care Provider, 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
- •Men aged 50 or older or women aged 55 or older
- •Be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
- •Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
- •Not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
排除标准
- •prevalent heart failure
- •History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI
- •History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis;
- •Allergy to fish or soy
研究组 & 干预措施
Vitamin D and fish oil
2000 IU per day and 1 g per day of fish oil
干预措施: Vitamin D and fish oil (Drug)
Vitamin D alone
2000 IU Vitamin D and fish oil placebo
干预措施: Vitamin D alone (Drug)
Fish oil (EPA/DHA) alone
1 g per day of fish oil and vitamin D placebo
干预措施: Fish oil (EPA/DHA) alone (Dietary Supplement)
Fish oil and vitamin D placebo
Placebo for both vitamin D and fish oil
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With New Heart Failure Hospitalization
时间窗: 5 years
We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis.
次要结局
- Number of Recurrent Heart Failure Hospitalization(5 years)
研究者
Luc Djousse
Director of Research, Associate Professor of Medicine
Brigham and Women's Hospital