The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are: * Will the use of alpha lipoic acid lower cardiovascular events in that population? * Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population? * Will the drug cause side effects? Participants will: * take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug. * be monitored for the occurrence of cardiovascular events (stroke, angina, etc.) * be monitored for the occurrence of side effects * give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme * undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet.
A Double-Blinded, Paralleled, Randomized, Placebo-Controlled Clinical Trial will be conducted at the Pediatric Nephrology and Dialysis Unit, Children's Hospital, Ain Shams University, Cairo, Egypt to detect the efficacy of alpha lipoic acid in reducing cardiovascular events by reducing oxidative stress-mediated endothelial dysfunction in pediatric population on regular hemodialysis by assessment of: 1. E-selectin as an Endothelial biomarker 2. SOD as an Oxidative stress biomarker 3. Indicators of CVS dysfunction by; * Duplex ultrasonography * Echocardiogram with stress on Ejection Fraction * Intimal medial thickness 4. Occurrence of CVS events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
50
THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA
Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid.
New Pediatrics Hospital, Faculty of Medicine, Ain Shams University
Cairo, El Weili, Egypt
Serum level of E-Selectin
The effect of ALA supplementation on the serum level of E-Selectin in pediatric patients on regular hemodialysis.
Time frame: at baseline and after the duration of treatment (6 months)
Serum levels of superoxide dismutase (SOD)
The effect of ALA supplementation on the serum level of SOD in pediatric patients on regular hemodialysis.
Time frame: at baseline and after the duration of treatment (6 months)
Number of cardiovascular events
Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring
Time frame: for the duration of treatment (6 months)
Number of Adverse effects
Evaluation of the safety of ALA supplementation in pediatric hemodialysis patients in terms of proportion of adverse drug events and complications.
Time frame: for the duration of treatment (6 months)
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