Alpha Lipoic Acid in Pediatrics on Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-02

Study Completion Date

2027-04-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Hemodialysis Complication Pediatric Kidney Disease Cardiovascular Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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(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.

Group Type EXPERIMENTAL

Alpha lipoic acid

Intervention Type DRUG

THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA

(Placebo) Control Group

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

Dose: One Tablet daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Alpha lipoic acid

THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Thioctic Acid

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No