A Protective Role of Alpha Lipoic Acid Against Possible Cardiovascular Events in Patients With Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Advanced glycation and oxidation end products (AGEs)
研究概览
简要总结
Evaluate the association between possible benefit effects of oral administration of alpha lipoic acid by patients with hemodialysis and the possible reduction in cardiovascular events (CVEs); using Advanced glycation end products (AGEs) as a measure to assess endothelium function which correlate with CVEs.
详细描述
Study design: double blind, Parallel, Randomized, Prospective, Controlled study. Setting: Nephrology Department, Dialysis units, Ain Shams University Hospitals, Ain Shams University, Cairo, Egypt.
Sample size:
36 patients with end-stage renal disease (ESRD) receiving dialysis treatment will be enrolled in the study and the patients will be identified by coded numbers to maintain the privacy.
Patients will be randomized into two groups each group includes 18 patients:
Control Group: 18 patients will receive their standard therapy only. Tested Group: 18 patients will receive alpha-lipoic acid (thiotacid R) product with their standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPatients eligible for the study fulfilled the following inclusion criteria and free from
排除标准
- •Inclusion criteria:
- •Clinical stable patients on hemodialysis for at least 3 months.
- •Aged between18 - 60 years old.
- •Both sexes.
- •Patients who accept to participate in the study.
- •Exclusion criteria:
- •The patients suffering from other diseases, which may lead to oxidative stress, such as: Inflammatory diseases, hepatic or respiratory diseases …
- •Smokers and alcoholics
- •Non-compliant patients
研究组 & 干预措施
Alpha-lipoic acid
18 patients will receive alpha lipoic acid (thiotacidR) product with their standard therapy.
干预措施: Alpha-Lipoic acid plus renal replacement therapy (Dietary Supplement)
Alpha-lipoic acid
18 patients will receive alpha lipoic acid (thiotacidR) product with their standard therapy.
干预措施: renal replacement therapy (Other)
Control
18 patients will receive their standard therapy only.
干预措施: renal replacement therapy (Other)
结局指标
主要结局
Advanced glycation and oxidation end products (AGEs)
时间窗: three months
Blood AGEs concentration was measured by fluorescence emission
次要结局
未报告次要终点
研究者
Rehab Werida
Lecturer
Damanhour University