Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- the prevalence of contrast-induced nephropathy
研究概览
简要总结
The investigators planned to research the effect of vitamin D supplementation on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography.
详细描述
Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Contrast-induced nephropathy (CIN) is a generally reversible form of acute kidney injury that occurs mostly within 2-3 days of exposure to contrast medium (CM). The estimated incidence of CIN ranges from 2%-50%, and coronary angiography (CAG) or percutaneous coronary intervention (PCI), or both, are associated with CIN in about half of cases. Recently low vitamin D status has been shown to be associated with increased risk of CIN. However, its effects on CIN patients remain unclear. The investigators planned to determine the efficacy of vitamin D on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in CIN 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria were patients who underwent coronary angiography.
排除标准
- •The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.
- •Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.
研究组 & 干预措施
Vitamin D supplementation group
drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: study treatment was commenced 3 days before intervention and maintained for 3 days after the procedure.
干预措施: vitamin D3 tablets (Drug)
Control group
drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: study treatment was commenced 3 days before intervention and maintained for 3 days after the procedure.
干预措施: placebo (Drug)
结局指标
主要结局
the prevalence of contrast-induced nephropathy
时间窗: 48-72h after treatment
The primary efficacy variable was the prevalence of CIN between the vitamin D group and the control group.
次要结局
- a change in serum creatinine level(at 1, 2, 3 days after percutaneous coronary intervention)
研究者
Shi Yang
Shi Yang
Chinese PLA General Hospital