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

Sponsor
Bahria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05817799
Collaborator
Pakistan Navy Station Shifa Hospital (Other), Jinnah Postgraduate Medical Centre (Other), University of Karachi (Other)
83
Enrollment
1
Location
2
Arms
6.2
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: L-Carnitine 500Mg thrice daily
  • Drug: 1g L-Carnitine IV three times a week
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
83 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Subjects of group B oral intervention group were given oral L-carnitine supplementation in the form of L-Carnitine tablets 500 mg thrice daily under strict monitoring for 5 months. The vitals were monitored daily during the course of supplementation. Subjects of group B intravenous group were given Intra venous L-Carnitine as a dose of 20mg/kg IV bolus infused over 2-3 minutes, administered into intra venous line after every hemodialysis session ( thrice a week) for 5 months. Complete general physical examination was done on every dialysis session. Patients were strictly monitored for the development of any signs of distress during the course of supplementation the drug. The patients and their attendants were educated about monitoring the vitals at home daily and to inform nephrologist immediately in case of any signs of allergy or distress. The supplementation was given after obtaining ethical approval and informed consent and under direct supervision of a Nephrologist.Subjects of group B oral intervention group were given oral L-carnitine supplementation in the form of L-Carnitine tablets 500 mg thrice daily under strict monitoring for 5 months. The vitals were monitored daily during the course of supplementation. Subjects of group B intravenous group were given Intra venous L-Carnitine as a dose of 20mg/kg IV bolus infused over 2-3 minutes, administered into intra venous line after every hemodialysis session ( thrice a week) for 5 months. Complete general physical examination was done on every dialysis session. Patients were strictly monitored for the development of any signs of distress during the course of supplementation the drug. The patients and their attendants were educated about monitoring the vitals at home daily and to inform nephrologist immediately in case of any signs of allergy or distress. The supplementation was given after obtaining ethical approval and informed consent and under direct supervision of a Nephrologist.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 2, 2023
Anticipated Study Completion Date :
Jul 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. L-Carnitine levels in hemodialysis [5 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jinnah Post Graduate Medical Center Karachi Sindh Pakistan 021

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sadia Rehman, Senior Assistant Professor, Bahria University
ClinicalTrials.gov Identifier:
NCT05817799
Other Study ID Numbers:
  • ERC 2022/23
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
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
Keywords provided by Sadia Rehman, Senior Assistant Professor, Bahria University
Hemodialysis
L-Carnitine
chronic kidney disease
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of Apr 18, 2023