Alpha Lipoic Acid in Pediatrics on Hemodialysis

Hemodialysis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286098
• Other study ID #: ALA in Pediatrics on HD
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 20, 2024
• Est. completion date: October 20, 2024

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: Mahmoud Mohsen, Pharmacist
• Phone: +201275811494
• Email: mahmoudfast41[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Complication
• Hemodialysis Complication
• Kidney Diseases
• Pediatric Kidney Disease

Intervention

Drug:
• Alpha lipoic acid
THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA

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

Locations

Country	Name	City	State
Egypt	New Pediatrics Hospital, Faculty of Medicine, Ain Shams University	Cairo	El Weili

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Eva Pharma

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Al-Nami MS, Al-Kuraishy HM, Al-Gareeb AI. Impact of thioctic acid on glycemic indices and associated inflammatory-induced endothelial dysfunction in patients with type 2 diabetes mellitus: A case control study. Int J Crit Illn Inj Sci. 2020 Sep;10(Suppl 1):21-27. doi: 10.4103/IJCIIS.IJCIIS_62_19. Epub 2020 Sep 16. — View Citation

Fogacci F, Rizzo M, Krogager C, Kennedy C, Georges CMG, Knezevic T, Liberopoulos E, Vallee A, Perez-Martinez P, Wenstedt EFE, Satrauskiene A, Vrablik M, Cicero AFG. Safety Evaluation of alpha-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies. Antioxidants (Basel). 2020 Oct 19;9(10):1011. doi: 10.3390/antiox9101011. — View Citation

Haghighatdoost F, Hariri M. The effect of alpha-lipoic acid on inflammatory mediators: a systematic review and meta-analysis on randomized clinical trials. Eur J Pharmacol. 2019 Apr 15;849:115-123. doi: 10.1016/j.ejphar.2019.01.065. Epub 2019 Feb 2. — View Citation

Huang EA, Gitelman SE. The effect of oral alpha-lipoic acid on oxidative stress in adolescents with type 1 diabetes mellitus. Pediatr Diabetes. 2008 Jun;9(3 Pt 2):69-73. doi: 10.1111/j.1399-5448.2007.00342.x. Epub 2008 Jan 22. — View Citation

Li LC, Tain YL, Kuo HC, Hsu CN. Cardiovascular diseases morbidity and mortality among children, adolescents and young adults with dialysis therapy. Front Public Health. 2023 Apr 12;11:1142414. doi: 10.3389/fpubh.2023.1142414. eCollection 2023. — View Citation

Malatino LS, Stancanelli B, Cataliotti A, Bellanuova I, Fatuzzo P, Rapisarda F, Leonardis D, Tripepi G, Mallamaci F, Zoccali C. Circulating E-selectin as a risk marker in patients with end-stage renal disease. J Intern Med. 2007 Oct;262(4):479-87. doi: 10.1111/j.1365-2796.2007.01841.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of E-Selectin	The effect of ALA supplementation on the serum level of E-Selectin in pediatric patients on regular hemodialysis.	at baseline and after the duration of treatment (6 months)
Secondary	Serum levels of superoxide dismutase (SOD)	The effect of ALA supplementation on the serum level of SOD in pediatric patients on regular hemodialysis.	at baseline and after the duration of treatment (6 months)
Secondary	Number of cardiovascular events	Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring	for the duration of treatment (6 months)
Secondary	Number of Adverse effects	Evaluation of the safety of ALA supplementation in pediatric hemodialysis patients in terms of proportion of adverse drug events and complications.	for the duration of treatment (6 months)