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Completed

NCT Number: NCT05817799

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

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.

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Key information

Conditions

Hemodialysis Complication Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Jinnah Post Graduate Medical Center

Karachi, Sindh, 021, Pakistan

About this study

.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-Carnitine 500Mg thrice daily

Drug

L-Carnitine 500mg oral thrice daily

1g L-Carnitine IV three times a week

Drug

1g IV L-Carnitine three times a week

Primary outcomes

  1. L-Carnitine levels in hemodialysis

    Time frame: 5 months

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

Sponsors and collaborators

Lead sponsor

Bahria University

Other

Collaborators

  • Jinnah Postgraduate Medical Centre
  • Pakistan Navy Station Shifa Hospital
  • University of Karachi

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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