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| Name | Class |
|---|---|
| Eva Pharma | INDUSTRY |
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The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:
Participants will:
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:
E-selectin as an Endothelial biomarker
SOD as an Oxidative stress biomarker
Indicators of CVS dysfunction by;
Occurrence of CVS events
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (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. |
|
| (Placebo) Control Group | Placebo Comparator | Placebo along with the standard care of therapy for a duration of 6 months. Dose: One Tablet daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha lipoic acid | Drug | THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of cardiovascular events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Mohsen, Pharmacist | Misr University for Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Pediatrics Hospital, Faculty of Medicine, Ain Shams University | Cairo | El Weili | 11381 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33086555 | Background | 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. | |
| 30721699 |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Placebo | Other | Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid. |
|
Counting the number of cardiovascular events (stroke, angina, etc.) through monitoring
| for the duration of treatment (6 months) |
| 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) |
| 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. |
| 18221433 | 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. |
| 37124791 | 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. |
| 17875185 | 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. |
| 33376686 | 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. |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |