Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum level of E-Selectin
研究概览
简要总结
The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:
- Will the use of alpha lipoic acid lower cardiovascular events in that population?
- Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?
- Will the drug cause side effects?
Participants will:
- take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.
- be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)
- be monitored for the occurrence of side effects
- give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme
- undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet.
详细描述
A Double-Blinded, Paralleled, Randomized, Placebo-Controlled Clinical Trial will be conducted at the Pediatric Nephrology and Dialysis Unit, Children's Hospital, Ain Shams University, Cairo, Egypt to detect the efficacy of alpha lipoic acid in reducing cardiovascular events by reducing oxidative stress-mediated endothelial dysfunction in pediatric population on regular hemodialysis by assessment of:
- E-selectin as an Endothelial biomarker
- SOD as an Oxidative stress biomarker
- Indicators of CVS dysfunction by;
- Duplex ultrasonography
- Echocardiogram with stress on Ejection Fraction
- Intimal medial thickness
- Occurrence of CVS events
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
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis.
- •The ability to swallow capsules will be enrolled in the study.
排除标准
- •Participants who suffered from severe congestive heart failure
- •Participants suffering from inflammatory diseases or other diseases that may increase oxidative stress.
- •Participants taking supplements that decrease oxidative stress or inflammatory markers
- •Participants with hypersensitivity to alpha lipoic acid
- •Participants who are non-compliant.
研究组 & 干预措施
(Alpha lipoic acid) Active Group
Alpha Lipoic Acid orally along with the standard care of therapy for a duration of 6 months.
Dose: 600 mg once daily.
干预措施: Alpha lipoic acid (Drug)
(Placebo) Control Group
Placebo along with the standard care of therapy for a duration of 6 months.
Dose: One Tablet daily.
干预措施: Placebo (Other)
结局指标
主要结局
Serum level of E-Selectin
时间窗: at baseline and after the duration of treatment (6 months)
The effect of ALA supplementation on the serum level of E-Selectin in pediatric patients on regular hemodialysis.
次要结局
- Serum levels of superoxide dismutase (SOD)(at baseline and after the duration of treatment (6 months))
- Number of Adverse effects(for the duration of treatment (6 months))
- Number of cardiovascular events(for the duration of treatment (6 months))
研究者
mahmoud mohsen
Researcher
Ain Shams University