NCT05817799

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Bahria University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hemodialysis Complication

Interventions

Type	Name	Description
DRUG	L-Carnitine 500Mg thrice daily	L-Carnitine 500mg oral thrice daily
DRUG	1g L-Carnitine IV three times a week	1g IV L-Carnitine three times a week

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-07-02
• Completion: 2023-07-10
• First posted: 2023-04-18
• Last updated: 2024-08-09

Locations

1 site across 1 country: Pakistan