Effects of 25-OH-D3 Vitamin Substitution in Congestive Heart Failure. Controlled, Randomized, Double Blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Survival rate
研究概览
简要总结
The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution improve the heart function in chronic heart failure.
Type of study: Controlled, randomized, double blind, placebo control
Number of patient: 300; 150 treated and 150 placebo controlled
Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month
Duration of study:1+1 year
Primary end points:
Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,
Secondary end points:
Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in 6 minutes
Visits:
Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA II-IV
- •vitamin D level between 10-30 ng/ml
- •ejection fraction by ultrasound < 40 %
排除标准
- •blood calcium > 2,6 mmol/l
- •urinary calcium > 0,1 mmol/body weight kg/die
- •blood phosphorus > 1,45 mmol/l
- •nephrolithiasis in the history
- •GFR < 30 ml/min
- •vitamin D injection in the last 6 month
- •actual 1,25-OH2-D3 vitamin treatment
- •Myocardial infarction or serious coronaria stenosis in the anamnesis uncontrolled atrial fibrillation
- •serious valve disease
研究组 & 干预措施
25-OH-D3 vitamin
180 000 IU 25-OH-D3 vitamin oil per os, per month in the 0, 1, 2, 3, and 6 month at the visit. The patient take the drug under medical control
干预措施: Vigantol oil and MCT oil (Drug)
MCT oil
9 ml MCT oil as placebo in the 0,1,2,3,6 month at the visit, under medical contol
干预措施: Vigantol oil and MCT oil (Drug)
结局指标
主要结局
Survival rate
时间窗: 2 years
次要结局
- serum brain natriuretic peptid level(2 years)
- well-being score(2 years)
- D-vitamin supplementation safety(1 year)
- walking test in 6 minutes(2 years)
- ejection fraction by ultrasound(2 years)
研究者
Istvan Takacs
Principal investigator
Semmelweis University