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ENROLLING BY INVITATION
NCT06286098
PHASE3

Alpha Lipoic Acid in Pediatrics on Hemodialysis

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

8 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-02-02

Completion Date

2028-03-01

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

New Pediatrics Hospital, Faculty of Medicine, Ain Shams University

Cairo, El Weili, Egypt