Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06901323
PHASE4

Effect of L-carnitine Supplementation on Phenylalanine and Brain-derived Neurotrophic Factor Levels in Infants and Children With Phenylketonuria

Sponsor: Mansoura University

View on ClinicalTrials.gov

Summary

Effect of L-carnitine supplementation on phenylalanine and brain-derived neurotrophic factor levels in infants and children with phenylketonuria L-carnitine is mainly obtained from foods such as red meat and milk that are limited for PKU patients due to dietary protein restriction. So, L-carnitine deficiency has been described in phenylketonuric patients The aim of this study is to : 1. Compare level of Brain-derived neurotrophic factor in infants and children with phenylketonuria and healthy infants and children. 2. Compare level of phenylalanine and Brain-derived neurotrophic factor before and after L-carnitine supplementation in phenylketonuric patients. 3. Assess Intelligence quotient test before and after L-carnitine supplementation in phenylketonuric patients

Official title: Effect of L-carnitine Supplementation on Phenylalanine and Brain-derived Neurotrophic Factor Levels in Infants and Children With Phenylketonuria Two Phases Study 1- Cross Sectional Comparative Study ( PKU Versus Non PKU Infants and Children). 2- Open Label Randomized Controlled Clinical Trial for PKU Patients Only. 1/ Intervention Group: 44 Patients Will Treated With L-carnitine at a Dose of 100 mg/kg/Dose for One Year Beside Their Treatment. 2/ Control PKU Group: 44 Patients Will Not Receive L-carnitine Supplementation Beside Their Treatment 3/ Control Healthy Group Same Age and Sex

Key Details

Gender

All

Age Range

1 Month - 18 Years

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2025-02-01

Completion Date

2026-08-01

Last Updated

2025-04-04

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

L-carnitine

44 patients diagnosed as a case of phenylketonuria will receive l-carnitine at a dose of 100 mg/kg/day for 1 year and then blood sample will examined for level of brain-derived neurotrophic factor levels before and after therapy and another group composed of 44 patients diagnosed as a case of phenylketonuria will not receive l-carnitine and their blood sample will examined for level of brain-derived neurotrophic factor levels treated and untreated patients will compared with healthy children and infants has same age and sex .

Locations (1)

Mansoura University

Al Mansurah, Egypt