Alpha Lipoic Acid in Pediatrics on Hemodialysis

Phase 3

• Conditions: Hemodialysis Complication; Pediatric Kidney Disease; Cardiovascular Complication
• Interventions: Other: Placebo; Drug: Alpha lipoic acid

• Registration Number: NCT06286098
• Lead Sponsor: Ain Shams University

Brief 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.

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 Timeline

• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-02-29
• Study Start: 2025-02-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-12-31
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Placebo) Control Group	Placebo	Placebo along with the standard care of therapy for a duration of 6 months. Dose: One Tablet daily.
(Alpha lipoic acid) Active Group	Alpha lipoic acid	Alpha Lipoic Acid orally along with the standard care of therapy for a duration of 6 months. Dose: 600 mg once daily.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Serum levels of superoxide dismutase (SOD)	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.
Number of Adverse effects	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.
Number of cardiovascular events	for the duration of treatment (6 months)	Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring

Trial Locations

Locations (1)

New Pediatrics Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, El Weili, Egypt