Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
Overview
- Phase
- Phase 3
- Status
- Enrolling By Invitation
- Sponsor
- Ain Shams University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Serum level of E-Selectin
Overview
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:
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 8 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
(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.
Intervention: Alpha lipoic acid (Drug)
(Placebo) Control Group
Placebo along with the standard care of therapy for a duration of 6 months.
Dose: One Tablet daily.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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
- Serum levels of superoxide dismutase (SOD)(at baseline and after the duration of treatment (6 months))
- Number of Adverse effects(for the duration of treatment (6 months))
- Number of cardiovascular events(for the duration of treatment (6 months))
Investigators
mahmoud mohsen
Researcher
Ain Shams University