Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- the improvement of coronary artery calcification
研究概览
简要总结
The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.
详细描述
We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D and the other will not. They will take coronary artery CT test every year(in 2 years).We will compare the coronary calcification progression between the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic kidney disease patients (3-5D)
- •serum 25（OH）D < 40nmol/L(16ng/ml)，serum calcium < 2.55mmol/L（10.2mg/dL）；
- •willing to sign
- •could obey the follow up design
排除标准
- •allergy to vitamin D
- •heart failure (NYHA more than 2 grade)
- •malignant tumor
- •critical hepatic disease
- •taking Vitamin D or analogue in 3 recent months
- •taking other clinical trial
研究组 & 干预措施
Treament
Intervention Vitamin D2
干预措施: Vitamin D2 (Drug)
结局指标
主要结局
the improvement of coronary artery calcification
时间窗: 2 years
We use CT to detect the coronary artery calcification score in the chronic kidney disease patients for 3 times (baseline, 12 month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。
次要结局
- the improvement of proteinuria(2 years)
研究者
Wang Mei
Professor
Peking University People's Hospital