Carnitine Supplementation in Pediatric Hemodialysis Patients

NCT05948124 | Unknown Early Phase 1

• 1 other identifier: Carnitine in Hemodialysis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is:

1. 1.To determine the prevalence of carnitine deficiency among pediatric patients on hemodialysis.
2. 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.

Conditions

Carnitine Deficiency Due to Hemodialysis

Outcome Measures

Primary Outcomes (7)

• change in serum free carnitine level

  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

  The investigator will assess ejection fraction percentage by Echocardiography.

  before supplementation and after six months of supplementation.

• change in hemoglobin level.

  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.

  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.

  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.

  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

  The investigator will measure fraction shortening percentage using Echocardiography

  before supplementation and after six months of supplementation.

Study Arms (2)

L-Carnitine Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

L-carnitine DRUG

L-carnitine supplementation

L-Carnitine Group

isotonic saline OTHER

Intravenous 5 ml of isotonic saline

Placebo Group

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Egypt

RECRUITING

Related Publications (3)

• Eknoyan G, Latos DL, Lindberg J; National Kidney Foundation Carnitine Consensus Conference. Practice recommendations for the use of L-carnitine in dialysis-related carnitine disorder. National Kidney Foundation Carnitine Consensus Conference. Am J Kidney Dis. 2003 Apr;41(4):868-76. doi: 10.1016/s0272-6386(03)00110-0.

  PMID: 12666074 BACKGROUND

• Evans A. Dialysis-related carnitine disorder and levocarnitine pharmacology. Am J Kidney Dis. 2003 Apr;41(4 Suppl 4):S13-26. doi: 10.1016/s0272-6386(03)00113-6.

  PMID: 12751050 BACKGROUND

• KDOQI Work Group. KDOQI Clinical Practice Guideline for Nutrition in Children with CKD: 2008 update. Executive summary. Am J Kidney Dis. 2009 Mar;53(3 Suppl 2):S11-104. doi: 10.1053/j.ajkd.2008.11.017. No abstract available.

  PMID: 19231749 BACKGROUND

MeSH Terms

Interventions

Carnitine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Fady LAbib

CONTACT

+201023811345/201282657642; Fadygeorguos@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: July 17, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)