NCT06286098

Alpha Lipoic Acid in Pediatrics on Hemodialysis

Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Hemodialysis Complication
• Pediatric Kidney Disease
• Cardiovascular Complication

Interventions

Type	Name	Description
DRUG	Alpha lipoic acid	THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA
OTHER	Placebo	Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid.

Timeline

• Start date: 2025-02-02
• Primary completion: 2027-11-30
• Completion: 2028-03-01
• First posted: 2024-02-29
• Last updated: 2026-03-02

Locations

1 site across 1 country: Egypt