Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05817799
Study type	Interventional
Source	Bahria University
Contact	Sadia Rehman, MBBS, MPhil
Phone	0343-4535510
Email	dr.sadia89@hotmail.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	January 1, 2023
Completion date	July 10, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms