Effect of Vitamin D on All-cause Mortality in Heart Failure Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of participants who died during the intervention
研究概览
简要总结
Despite significant therapeutic improvements, congestive heart failure (CHF) patients still have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an accumulating body of evidence from prospective cohort studies that low circulating 25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality, respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether vitamin D supplementation reduces mortality and increases event-free survival in end-stage CHF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age and < 80 years of age
- •New York Heart Association Functional Class > = II
排除标准
- •pregnancy and lactation
- •sarcoidosis
- •daily vitamin D intake > 20 micrograms
- •serum 25-hydroxyvitamin D > 30 ng/ml
- •hypercalcemia
研究组 & 干预措施
Vitamin D
daily vitamin D supplement
干预措施: Vitamin D (Drug)
placebo
daily placebo supplement
干预措施: placebo (Drug)
结局指标
主要结局
Number of participants who died during the intervention
时间窗: three years
all-cause mortality (any cause of death) will be assessed
次要结局
- Number of event-free survivors(three years)
- Changes in biochemical risk markers(three years)
- Number of participants with elevated safety parameters(every 6 months)