Alpha Lipoic Acid in Pediatrics on Hemodialysis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Alpha lipoic acid, Placebo.
- Кому может быть актуально
- Состояния в реестре: Hemodialysis Complication, Pediatric Kidney Disease, Cardiovascular Complication. Базовые параметры: 8 лет — 16 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effect of Alpha Lipoic Acid on the Clinical Outcome of Pediatric Patients Undergoing Hemodialysis
Обзор
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.
Подробное описание
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
Вмешательства
- Препарат Alpha lipoic acid
THIOTACID 600 MG ORIGINAL ® Tablets manufactured by EVA PHARMA - Другое Placebo
Placebo identical Tablets are manufactured by EVA PHARMA containing the same excipients without Alpha Lipoic Acid.
Первичные конечные точки
- Serum level of E-Selectin [Срок оценки: at baseline and after the duration of treatment (6 months)]
Вторичные конечные точки (3)
- Serum levels of superoxide dismutase (SOD) [Срок оценки: at baseline and after the duration of treatment (6 months)]
- Number of cardiovascular events [Срок оценки: for the duration of treatment (6 months)]
- Number of Adverse effects [Срок оценки: for the duration of treatment (6 months)]
Критерии участия
Критерии включения
- Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis.
- The ability to swallow capsules will be enrolled in the study.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Египет · 1 центр
- New Pediatrics Hospital, Faculty of Medicine, Ain Shams University — Cairo
Публикации
- 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
- 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
- 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
- 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
- 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
- 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
Идентификаторы
NCT: NCT06286098 · ALA in Pediatrics on HD