NCT01457001终止3 期
Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.
Italian Society of Nephrology28 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 284
- 试验地点
- 28
- 主要终点
- Vital status
研究概览
简要总结
Multicentric randomized Italian clinical trial, open label, not for profit. To evaluate the efficacy of 25-OH-D vitamin in terms of myocardial infarction, stroke, sudden death, death for other causes in chronic haemodialysis patients. Two arms of treatment: 25-OH-D vitamin per os versus no treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18 years
- •hematic PTH level twofold-ninefold the upper limit
- •hematic level of 25-OH-D vitamin < 30 ng/ml
排除标准
- •renal transplant or peritoneal dialysis less than 3 years ago
- •pregnancy
- •breastfeeding
研究组 & 干预措施
25-OH-D vitamin
Experimental
干预措施: 25-OH-D vitamin (Drug)
结局指标
主要结局
Vital status
时间窗: During the follow up, every three months for three years
Death for all causes but traumatic.
Onset of non fatal myocardial infarction
时间窗: During the follow up, every three months for three years
Cumulative with the vital status
Onset of non fatal stroke
时间窗: During the follow up, every three months for three years
Cumulative with the vital status
次要结局
- fatal stroke(During the follow up, every three months for three years)
- death for other causes (not traumatic)(During the follow up, every three months for three years)
- frequency of hypercalcemia (>10.5 mg/dl)(During the follow up, every three months for three years)
- frequency of hyperphosphoremia (>5.5 mg/dl)(During the follow up, every three months for three years)
- frequency of normal level of 25-OH-D vitamin (>30 ng/ml)(During the follow up, every three months for three years)
- frequency of 25-OH-D vitamin >100 ng/ml(During the follow up, every three months for three years)
- frequency of reduction of therapy with calcitriol and/or paricalcitol and/or calcium mimetics and/or phosphorus chelators(During the follow up, every three months for three years)
- frequency of parathyroid surgery(During the follow up, every three months for three years)
- fatal myocardial infarction(During the follow up, every three months for three years)
- non fatal myocardial infarction(During the follow up, every three months for three years)
- non fatal stroke(During the follow up, every three months for three years)
- sudden death(During the follow up, every three months for three years)
研究者
研究点 (28)
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