Impact of Cholecalciferol Supplementation in Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml
研究概览
简要总结
This is prospective single-blind randomized study, in Ain Shams University hospital) in Egypt, to assess the impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients
详细描述
This Srudy is to assess the Impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients in terms of increase of Hgb >11 g/dl, transferrin saturation (TSAT) of ≥ 30%, and ferritin levels to achieve a range of (300 to < 800 ng/ml), and effect on Epoetin Dose needed. This study is also to adress the factors affecting the correcetion of Anemia by Cholecalciferol supplementation, such as oxidative stress and Inflammatory markers.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •: Male or female patients who are willing to participate in the trial should have been on maintenance hemodialysis sessions for not less than 3 months, aged between 18-70 years old, clinically stable (no prior hospitalization on the past three months), with serum 25(OH)D levels of less than 30 ng/ml and their iPTH levels of 150-800 pg/ml, and hemoglobin levels of less than 11 mg/dl.
排除标准
- •Patients with previous or known hypersensitivity to cholecalciferol,
- •Patients who are already on cholecalciferol therapy, or patients on immunosuppressants.
- •Blood transfusion in the past 4 month, and patients who had anemia for other than renal causes,
- •Those who were participating in another clinical trial within the past 4 weeks or pregnant/breastfeeding female patients were excluded as well.
研究组 & 干预措施
Group A
Group A: Weekly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, for 3 months' duration
干预措施: Cholecalciferol (Drug)
Group B
Group b: Monthly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 200.00IU Cholecalciferol, once monthly, for 3 months' duration
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml
时间窗: 3 months
次要结局
- TSAT levels to be ≥ 30%(3 months)
- Ferritin levels to be > 300 ng/ml, but not exceeding 800 ng/ml(3 months)
- Increase in hemoglobin (Hgb) levels (11-13 mg/dl),(3 months)
研究者
Mona AlShahawey Ghazy, PhD
Assistant Professor of Clinical Pharmacy
Ain Shams University