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Alpha Lipoic Acid in Pediatrics on Hemodialysis

NCT06286098 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-02

No results posted yet for this 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.

Conditions

  • Hemodialysis Complication
  • Pediatric Kidney Disease
  • Cardiovascular Complication

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.

Sponsors & Collaborators

  • Eva Pharma

    collaborator INDUSTRY

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mahmoud Mohsen, Pharmacist · Misr University for Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-02
Primary Completion
2027-11-30
Completion
2028-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286098 on ClinicalTrials.gov