Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- L-Carnitine levels in hemodialysis
研究概览
简要总结
OBJECTIVES
- To assess the levels of plasma carnitine in controls and hemodialysis patients.
- To give supplementary L-carnitine to study subjects for a duration of 5months.
- To compare the values of plasma carnitine before and after L carnitine supplementation.
- To assess the role of carnitine supplementation on biochemical and clinical parameters.
详细描述
.ABSTRACT INTRODUCTION Dialysis therapy can cause a decrease in both free carnitine and plasma acyl carnitines after only six months of dialysis treatment. A positive correlation between AC/FC ratio and months on HD therapy has been reported. We investigate in this study the role of oral L-carnitine supplementation on anemia, blood pressure, cardiac dysfunction and muscle cramps in hemodialysis patients.
OBJECTIVES
- To assess the levels of plasma carnitine in controls and hemodialysis patients.
- To give supplementary L-carnitine to study subjects for a duration of 5months.
- To compare the values of plasma carnitine before and after L carnitine supplementation.
- To assess the role of carnitine supplementation on biochemical and clinical parameters.
STUDY DESIGN AND SETTING: It will be a case-control study, which will be conducted in the Department of Biochemistry, University of Karachi in collaboration with Nephrology ward of JPMC, Karachi in a period of one year after approval of synopsis.
METHOD: Total 120 subjects will be included in this study which will be divided into two groups. Group A will comprise of 60 subjects of Chronic renal failure who will be the control group. Group B will comprise of 60 subjects who will be on hemodialysis for more than 1 year. Blood samples will be taken after informed consent. Group B subjects will be given L-Carnitine supplementation for five months under strict monitoring. Physical, biochemical and clinical parameters of group B subjects will be compared before and after supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of either sex (male and female).
- •The study included people between the ages of 18 and 50 who had had dialysis for more than two years without taking additional antioxidants.
排除标准
- •• Individuals with any other chronic ailment, such as cancer or tuberculosis.
- •Patients with acute renal failure who are receiving hemodialysis.
- •All subjects who refused to take part in the investigation.
研究组 & 干预措施
intervention
L-Carnitine 500mg thrice daily
1g L-Carnitine IV three times a week
干预措施: L-Carnitine 500Mg thrice daily (Drug)
intervention
L-Carnitine 500mg thrice daily
1g L-Carnitine IV three times a week
干预措施: 1g L-Carnitine IV three times a week (Drug)
结局指标
主要结局
L-Carnitine levels in hemodialysis
时间窗: 5 months
plasma carnitine will be detected before and after giving intervention (unit μmol/L)
次要结局
未报告次要终点
研究者
Sadia Rehman
Senior Assistant Professor
Bahria University
