Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286098
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-02-23
Brief Title:
Alpha Lipoic Acid in Pediatrics on Hemodialysis
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Childrens 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None