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

Bahria University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemodialysis Complication

Treatments: Drug: L-Carnitine 500Mg thrice daily; Drug: 1g L-Carnitine IV three times a week

Study type: Interventional

Funder types: Other

Identifiers

NCT05817799

ERC 2022/23

Details and patient eligibility

About

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.

Full description

.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.

RESULTS: Data will be analyzed using SPSS version 21. Results will be shared after completion of research.

CONCLUSION: conclusion will be shared after completion of research.

Enrollment: 83 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: • 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.

Exclusion Criteria:

• • 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

intervention

Experimental group

Description:

L-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week

Treatment:

Drug: 1g L-Carnitine IV three times a week

Drug: L-Carnitine 500Mg thrice daily

control

No Intervention group

Description:

no intervention given