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

August 7, 2024 updated by: Sadia Rehman, Bahria University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 021
        • Jinnah Post Graduate Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention

L-Carnitine 500mg thrice daily

1g L-Carnitine IV three times a week
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
No Intervention: control
no intervention given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
L-Carnitine levels in hemodialysis
Time Frame: 5 months
plasma carnitine will be detected before and after giving intervention (unit μmol/L)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahria University

Collaborators

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

Investigators

  • Principal Investigator: Sadia Rehman, Bahria University Health Sciences, Karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

July 2, 2023

Study Completion (Actual)

July 10, 2023

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC 2022/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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