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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05817799
Enrollment
83
Registered
2023-04-18
Start date
2023-01-01
Completion date
2023-07-10
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Complication

Keywords

Hemodialysis, L-Carnitine, chronic kidney disease

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.

Interventions

DRUG1g L-Carnitine IV three times a week

1g IV L-Carnitine three times a week

DRUGL-Carnitine 500Mg thrice daily

L-Carnitine 500mg oral thrice daily

Sponsors

Pakistan Navy Station Shifa Hospital
CollaboratorOTHER
Jinnah Postgraduate Medical Centre
CollaboratorOTHER_GOV
University of Karachi
CollaboratorOTHER
Bahria University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
L-Carnitine levels in hemodialysis5 monthsplasma carnitine will be detected before and after giving intervention (unit μmol/L)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026