NCT01561222Unknown4 期
Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Osteoprotegin level
研究概览
简要总结
Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Clinical diagnosis of CKD stage 1 and 2
- •Age >18 years
- •Ability to provide informed consent
排除标准
- •On vitamin D in past 4 weeks
- •Plans to relocate out of Taixing City in the next one year
- •Serum phosphate >5.5 mg/dl in past 3 months
- •Serum calcium >10.0 mg/dl in past 3 months
- •Transplanted organ
- •Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
Calcitriol
Experimental
干预措施: Calcitriol (Drug)
结局指标
主要结局
Osteoprotegin level
时间窗: one year
To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients
次要结局
- Bone mineral density(one year)
- vascular calcification score(one year)
研究者
Xu Zhang
Zhang Xu
Taixing People's Hospital
研究点 (1)
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