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临床试验/NCT01561222
NCT01561222Unknown4 期

Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2

Taixing People's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年7月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Zhang

Zhang Xu

Taixing People's Hospital

研究点 (1)

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