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

ALA in Pediatrics on HD

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.

2024-03-20

2024-09-20

2024-10-20

Not yet recruiting

Early phase I

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 any previous cardiovascular event. * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-03-12