Alpha Lipoic Acid in Pediatrics on Hemodialysis

NCT06286098 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Phase 3

Started

2025-02-02

Last updated

2026-03-02

Condition(s) studied

Hemodialysis ComplicationPediatric Kidney DiseaseCardiovascular Complication

Investigational drug(s) / intervention(s)

Alpha lipoic acid →Placebo

Alpha lipoic acid: THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA

Placebo: Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid.

Study 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.

Eligibility

Sex

ALL

Min age

8 Years

Max age

16 Years

Healthy volunteers

Inclusion Criteria: * Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis. * The ability to swallow capsules will be enrolled in the study. Exclusion Criteria: * Participants who suffered from severe congestive heart failure * Participants suffering from inflammatory diseases or other diseases that may increase oxidative stress. * Participants taking supplements that decrease oxidative stress or inflammatory markers * Participants with hypersensitivity to alpha lipoic acid * Participants who are non-compliant.

Primary outcome measure(s)

Serum level of E-Selectin — at baseline and after the duration of treatment (6 months)
The effect of ALA supplementation on the serum level of E-Selectin in pediatric patients on regular hemodialysis.

Trial sites (1)

Facility	City	Region	Status
New Pediatrics Hospital, Faculty of Medicine, Ain Shams University	Cairo	El Weili

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06286098 on ClinicalTrials.gov ↗ ← All trials in Egypt