Carnitine Supplementation in Pediatric Hemodialysis Patients

July 13, 2023 updated by: Fady georguos labib, Ain Shams University

Carnitine Deficiency and Benefits of Its Supplementation in Pediatric Hemodialysis Patients

The goal of this study is:

  1. To determine the prevalence of carnitine deficiency among pediatric patients on hemodialysis.
  2. To evaluate the efficiency of carnitine supplementation in children on regular hemodialysis with carnitine deficiency in the treatment of renal anemia, cardiac dysfunction, dyslipidemia, intradialytic muscle cramps and hypotension and their quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients on hemodialysis (HD) often have carnitine deficiency due to multiple factors; dietary intake of carnitine is decreased due to falls in appetite, total energy levels, and protein intake. In addition, accumulating evidence has linked inflammation to malnutrition, and chronic inflammation might also interrupt carnitine transfer in the intestine. Carnitine biosynthesis can also fall in patients on dialysis due to reduced biosynthesis in the kidney and limited compensation by the liver. Furthermore, because of the low molecular weight of carnitine and its high hydrophilicity and absence of protein binding, carnitine is significantly removed by the dialyzer. As in the healthy population, carnitine deficiency in patients receiving maintenance dialysis is most commonly defined as a serum free carnitine level less than 20 μmol/L .

Intravenous levocarnitine is commonly used to treat patients receiving maintenance hemodialysis who are diagnosed with carnitine deficiency since it has 100%bioavailability and does not break down into toxic metabolites. A common dose used for carnitine supplementation is 10-20 mg/kg administered after each hemodialysis session, which produces the supraphysiologic serum levels of carnitine that are required to adequately drive carnitine from the serum into skeletal muscles.

There are four principal indications for levocarnitine treatment in dialysis patients with carnitine deficiency according to the American National Kidney Foundation: (1) erythropoiesis stimulating agents resistant anemia that has not responded to the standard erythropoiesis stimulating agent dosage; (2) recurrent symptomatic hypotension during hemodialysis;(3) symptomatic cardiomyopathy or confirmed cardiomyopathy with reduced left ventricular ejection fraction and(4) fatigability and muscle weakness that undermine the quality of life.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University
        • Contact:
          • Ainshams university Hospitals

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients on regular hemodialysis for more than three months with L-carnitine deficiency.
  • Anemia (hemoglobin [Hb] < 11 g/dl; hematocrit [Hct] < 30%) resistant to erythropoietin defined as Anemia that require recombinant human erythropoietin (rHuEPO) doses >300 units/kg/week intravenously in spite of adequate iron stores (transferrin saturation >20%, ferritin >100 ng/mL), and without any other identifiable cause of anemia.
  • Recurrent intradialytic complications (cramping, muscular pain, hypotension)
  • Cardiomyopathy with reduced left ventricular ejection fraction.
  • Sex: both males and females.
  • Age: 16 years old or less.

Exclusion criteria:

  • Patients known to be allergic to L-carnitine.
  • Patients with inborn error of metabolism.
  • Patients on lipid lowering therapy.
  • Patients with Diabetes mellitus.
  • Patients with Associated congenital heart disease.
  • Patients with Thyroid disorder, or malignancy.
  • Patients received L-carnitine within the past 6 months.
  • Patients received Blood transfusion 4 weeks prior to study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-Carnitine Group
Enrolled patients in this group who are on regular hemodialysis fulfilling our study's inclusion criteria with secondary carnitine deficiency(based on clinical manifestations and decreased serum level of L-carnitine ;serum free carnitine level less than 20 μmol/L) will receive intravenous L-carnitine (20 mg/kg dry body weight) after each dialysis session three times weekly for 6 months.
Drug: L-carnitine
L-carnitine supplementation
Placebo Comparator: Placebo Group
enrolled patients in this group who will receive 5 ml intravenous isotonic saline after each dialysis session three times weekly for 6 months.
Other: isotonic saline
Intravenous 5 ml of isotonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in serum free carnitine level
Time Frame: before supplementation and after six months of supplementation.
The investigator will measure serum free carnitine level in blood using ELISA technique.
before supplementation and after six months of supplementation.
change in cardiac functions
Time Frame: before supplementation and after six months of supplementation.
The investigator will assess ejection fraction percentage by Echocardiography.
before supplementation and after six months of supplementation.
change in hemoglobin level.
Time Frame: before supplementation and after six months of supplementation.
The investigator will measure hemoglobin level to assess effect of supplementation on renal anemia. and Erythropoietin dose
before supplementation and after six months of supplementation.
change in Body composition.
Time Frame: before supplementation and after six months of supplementation.
using (The Fresenius Medical Care Body Composition Monitor - BCM) to assess fat composition percentiles.
before supplementation and after six months of supplementation.
change in Body composition.
Time Frame: before supplementation and after six months of supplementation.
using (The Fresenius Medical Care Body Composition Monitor - BCM) to assess lean tissue index percentiles.
before supplementation and after six months of supplementation.
change in quality of life.
Time Frame: before supplementation and after six months of supplementation.
assessment of quality of life using 36 -item short form survey instrument (SF- 36) questionnaire, it is a perceived quality of life assessment tool which will be used to assess general health, physical functioning, bodily pain, and mental health with a scale 0 - 100 , The lower the score the more disability.
before supplementation and after six months of supplementation.
change in Cardiac functions
Time Frame: before supplementation and after six months of supplementation.
The investigator will measure fraction shortening percentage using Echocardiography
before supplementation and after six months of supplementation.

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 17, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Carnitine in Hemodialysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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