Clinical trial NCT05817799: Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
Official title: Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hemodialysis Complication
Keywords: Hemodialysis
L-Carnitine
chronic kidney disease
Lead sponsor: Bahria University
Sponsor class: OTHER
Collaborators: name: Pakistan Navy Station Shifa Hospital
name: Jinnah Postgraduate Medical Centre
name: University of Karachi
First posted: 2023-04-18
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: L-Carnitine levels in hemodialysis
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Post Graduate Medical Center
state: Sindh
Study officials:
affiliation: Bahria University Health Sciences, Karachi
name: Sadia Rehman
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hamedi-Kalajahi F, Imani H, Mojtahedi S, Shabbidar S. Effect of L-Carnitine Supplementation on Inflammatory Markers and Serum Glucose in Hemodialysis Children: A Randomized, Placebo-Controlled Clinical Trial. J Ren Nutr. 2022 Mar;32(2):144-151. doi: 10.1053/j.jrn.2021.03.009. Epub 2021 Nov 3.