Cardiovascular Complication, Hemodialysis Complication, Pediatric Kidney Disease
Conditions
Keywords
Alpha Lipoic Acid, alpha-lipoic acid, Thioctic acid, Hemodialysis, E-selectin, eselectin, Children Kidney
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
Interventions
DRUGAlpha lipoic acid
THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA
OTHERPlacebo
Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid.
Sponsors
Ain Shams University
Eva Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 cardiovascular events | for the duration of treatment (6 months) | Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring |
| 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMahmoud Mohsen, Pharmacist
Misr University for Science and Technology
Outcome results
None listed