Alpha Lipoic Acid in Pediatrics on Hemodialysis

NCT06286098 | Enrolling By Invitation Phase 3

• 1 other identifier: ALA in Pediatrics on HD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Pediatric Kidney Disease; Cardiovascular Complication

Keywords

Alpha Lipoic Acid; alpha-lipoic acid; Thioctic acid; Hemodialysis; E-selectin; eselectin; Children Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Serum levels of superoxide dismutase (SOD)

  at baseline and after the duration of treatment (6 months)

• Number of cardiovascular events

  for the duration of treatment (6 months)

• Number of Adverse effects

  for the duration of treatment (6 months)

Study Arms (2)

(Alpha lipoic acid) Active Group

EXPERIMENTAL

Alpha Lipoic Acid orally along with the standard care of therapy for a duration of 6 months. Dose: 600 mg once daily.

Drug: Alpha lipoic acid

(Placebo) Control Group

PLACEBO COMPARATOR

Placebo along with the standard care of therapy for a duration of 6 months. Dose: One Tablet daily.

Other: Placebo

Interventions

Alpha lipoic acid DRUG

THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA

Also known as: Thioctic Acid

(Alpha lipoic acid) Active Group

Placebo OTHER

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

(Placebo) Control Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis.
• The ability to swallow capsules will be enrolled in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eva Pharma: collaborator
• Ain Shams University: lead

Study Sites (1)

New Pediatrics Hospital, Faculty of Medicine, Ain Shams University

Cairo, El Weili, 11381, Egypt

Location

Related Publications (6)

• 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.

  PMID: 33086555 BACKGROUND

• 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.

  PMID: 30721699 BACKGROUND

• 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.

  PMID: 18221433 BACKGROUND

• 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.

  PMID: 37124791 BACKGROUND

• 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.

  PMID: 17875185 BACKGROUND

• 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.

  PMID: 33376686 BACKGROUND

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Mahmoud Mohsen, Pharmacist

  Misr University for Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: February 29, 2024
• Study Start: February 2, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2025-04

Locations

EG (1)