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

Phase 2
Completed
Conditions
Hemodialysis Complication
Interventions
Registration Number
NCT05817799
Lead Sponsor
Bahria University
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
83
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
interventionL-Carnitine 500Mg thrice dailyL-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week
intervention1g L-Carnitine IV three times a weekL-Carnitine 500mg thrice daily 1g L-Carnitine IV three times a week
Primary Outcome Measures
NameTimeMethod
L-Carnitine levels in hemodialysis5 months

plasma carnitine will be detected before and after giving intervention (unit μmol/L)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Jinnah Post Graduate Medical Center

🇵🇰

Karachi, Sindh, Pakistan

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