NCT03602430已完成2 期
Effect of Cholecalciferol on Hemodialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vitamin D level
研究概览
简要总结
- Screening the prevalence of vitamin D deficiency among Egyptian hemodialysis patients on a single center (Ain Shams University hospital).
- Assessing the effect of the native type of vitamin D (Cholecalciferol) on replenishing its deficiency via extra-renal vitamin D receptors (VDR), among Egyptian hemodialysis patients.
- Assessing the effect of cholecalciferol on vascular calcification among Egyptian hemodialysis patients.
- Assessing the effect of cholecalciferol on Blood pressure, parathyroid hormone.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Both sexes aged between 18-75 years
- •Patients on HD greater than 3 months at least.
- •Stable clinical condition (no hospitalization in the previous 3 months)
- •Informed consent in accordance with the Declaration of Helsinki.
- •PTH level between 150 - 800 pg/ml.
排除标准
- •Hypersensitivity to cholecalciferol.
- •Participant in an another clinical trial within the past 4 weeks.
- •Judged to be unsuitable as a subject by the attending physician.
- •Pregnant or breastfeeding female
研究组 & 干预措施
Drug Group
Experimental
twenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period
干预措施: Cholecalciferol (Drug)
Placebo Group
Placebo Comparator
twenty-five patients will receive a placebo ampule with their standard treatment for 3 months period.
干预措施: Placebo (Drug)
结局指标
主要结局
Vitamin D level
时间窗: 3 months
Target serum Vitamin D level ≥ 30 ng/ml
次要结局
未报告次要终点
研究者
Mona AlShahawey AlSayed Ghazy
Assistant lecturer of Clinical Pharmacy
Ain Shams University
研究点 (1)
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