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