Hemodialysis Complication Clinical Trial
Official title:
Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | New Pediatrics Hospital, Faculty of Medicine, Ain Shams University | Cairo | El Weili |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University | Eva Pharma |
Egypt,
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
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) |
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