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Enrolling by Invitation

NCT Number: NCT06286098

Alpha Lipoic Acid in Pediatrics on 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.

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Key information

Conditions

Hemodialysis Complication Cardiovascular Complication Pediatric Kidney Disease

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New Pediatrics Hospital, Faculty of Medicine, Ain Shams University

Cairo, El Weili, 11381, Egypt

About this study

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:

  • E-selectin as an Endothelial biomarker
  • SOD as an Oxidative stress biomarker
  • Indicators of CVS dysfunction by;
  • Duplex ultrasonography
  • Echocardiogram with stress on Ejection Fraction
  • Intimal medial thickness
  • Occurrence of CVS events

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alpha lipoic acid

Drug

THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA

Other names: Thioctic Acid

Placebo

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Number of cardiovascular events

    Time frame: for the duration of treatment (6 months)

    Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring

  3. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Eva Pharma

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 29, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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