NCT01312714已完成2 期
A Randomized, Placebo-Controlled, Double Blind Study Evaluating the Effect of Cholecalciferol on Vasoactive Hormones, Heart Function, Arterial Stiffness, and Blood Pressure in Dialysis Patients.
Regional Hospital Holstebro1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Plasma concentration of NT-proBNP
研究概览
简要总结
Vitamin D deficiency is highly prevalent among dialysis patients, and has been associated with cardiovascular risk factors such as increased aortic pulse wave velocity, blood pressure, inflammation, and brain natriuretic peptide. This study will evaluate the effect of 26 weeks of vitamin D3 supplementation in patients with end stage renal disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis or peritoneal dialysis > 3 months
排除标准
- •Hypercalceamia
- •Inability to give informed consent
研究组 & 干预措施
Cholecalciferol
Active Comparator
干预措施: Cholecalciferol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma concentration of NT-proBNP
时间窗: 26 weeks
次要结局
- 24-hour blood pressure(26 weeks)
- Plasma concentration of ionized calcium(4 weeks)
- Plasma concentration of phosphate(4 weeks)
- Plasma concentration of PTH(4 weeks)
- Plasma concentration of 25-hydroxycholecalciferol(4 weeks)
- Plasma renin concentration(26 weeks)
- Plasma concentration of angiotensin II(26 weeks)
- Plasma concentration of aldosterone(26 weeks)
- Arterial stiffness(26 weeks)
- Serum concentration of FGF-23(26 weeks)
- Plasma concentration of AVP(26 weeks)
- Plasma concentration of ANP(26 weeks)
- Plasma concentration of TNF alpha(26 weeks)
- Heart Function(26 weeks)
研究者
Erling Bjerregaard Pedersen
DMSc
Regional Hospital Holstebro
研究点 (1)
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