Clinical trial NCT06286098: Alpha Lipoic Acid in Pediatrics on Hemodialysis
Official title: Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Hemodialysis Complication
Pediatric Kidney Disease
Cardiovascular Complication
Keywords: Alpha Lipoic Acid
alpha-lipoic acid
Thioctic acid
Hemodialysis
E-selectin
eselectin
Children Kidney
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Eva Pharma
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Serum level of E-Selectin
timeFrame: at baseline and after the duration of treatment (6 months)
Secondary outcomes:
measure: Serum levels of superoxide dismutase (SOD)
timeFrame: at baseline and after the duration of treatment (6 months)
measure: Number of cardiovascular events
timeFrame: for the duration of treatment (6 months)
measure: Number of Adverse effects
timeFrame: for the duration of treatment (6 months)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: New Pediatrics Hospital, Faculty of Medicine, Ain Shams University
state: El Weili
Study officials:
affiliation: Misr University for Science and Technology
name: Mahmoud Mohsen, Pharmacist
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
citation: 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.