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临床试验/NCT05817799
NCT05817799已完成2 期

Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease

Bahria University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2023年1月1日最近更新:
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
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

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

Experimental

L-Carnitine 500mg thrice daily

1g L-Carnitine IV three times a week

干预措施: L-Carnitine 500Mg thrice daily (Drug)

intervention

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sadia Rehman

Senior Assistant Professor

Bahria University

研究点 (1)

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