Alpha Lipoic Acid in Pediatrics on Hemodialysis

February 27, 2026 updated by: mahmoud mohsen, Ain Shams University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Weili
      • Cairo, El Weili, Egypt, 11381
        • New Pediatrics Hospital, Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (Alpha lipoic acid) Active Group

Alpha Lipoic Acid orally along with the standard care of therapy for a duration of 6 months.

Dose: 600 mg once daily.
Drug: Alpha lipoic acid
THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA
Other Names:
  • Thioctic Acid
Placebo Comparator: (Placebo) Control Group

Placebo along with the standard care of therapy for a duration of 6 months.

Dose: One Tablet daily.
Other: Placebo
Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of E-Selectin
Time Frame: 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.
at baseline and after the duration of treatment (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of superoxide dismutase (SOD)
Time Frame: at baseline and after the duration of treatment (6 months)
The effect of ALA supplementation on the serum level of SOD in pediatric patients on regular hemodialysis.
at baseline and after the duration of treatment (6 months)
Number of cardiovascular events
Time Frame: for the duration of treatment (6 months)
Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring
for the duration of treatment (6 months)
Number of Adverse effects
Time Frame: for the duration of treatment (6 months)
Evaluation of the safety of ALA supplementation in pediatric hemodialysis patients in terms of proportion of adverse drug events and complications.
for the duration of treatment (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Eva Pharma

Investigators

  • Principal Investigator: Mahmoud Mohsen, Pharmacist, Misr University for Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALA in Pediatrics on HD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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