Alpha Lipoic Acid in Pediatrics on Hemodialysis

Ain Shams University

Status and phase: Invitation-only; Phase 3

Conditions: Hemodialysis Complication; Cardiovascular Complication; Pediatric Kidney Disease

Treatments: Drug: Alpha lipoic acid; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06286098

ALA in Pediatrics on HD

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

(Alpha lipoic acid) Active Group

Experimental group

Description:

Alpha Lipoic Acid orally along with the standard care of therapy for a duration of 6 months. Dose: 600 mg once daily.

Treatment:

Drug: Alpha lipoic acid

(Placebo) Control Group

Placebo Comparator group

Description:

Placebo along with the standard care of therapy for a duration of 6 months. Dose: One Tablet daily.

Treatment:

Other: Placebo