Department of Pediatrics, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.
J Pediatr Endocrinol Metab. 2021 May 4;34(7):897-904. doi: 10.1515/jpem-2020-0642. Print 2021 Jul 27.
Nonalcoholic fatty liver disease (NAFLD) is one of the most common liver diseases in the pediatric population at global level. Present study aims to assess the effect of l-carnitine supplementation on the NAFLD in children and adolescents.
This randomized, triple-blind, placebo-controlled clinical trial was conducted in 2018-2019. Study was carried out in NAFLD participants (5-15 years). They were randomly assigned to receive either 50 mg/kg/day l-carnitine twice a day or identical placebo per day for three months. Liver enzymes and liver ultrasonography were assessed before and after the intervention. Both groups received similar consultation for lifestyle changes.
Overall, 55 participants completed the study, 30 patients in the l-carnitine group and 25 patients in placebo group. Mean changes of anthropometric measurements did not have significant differences between groups (p>0.05). No significant differences in the mean changes of aspartate aminotransferase (AST) (p=0.82) and alanine aminotransferase (ALT) (p=0.76) levels were documented between two groups. Based on within-group analysis, there were significant changes in AST and ALT levels before and after the intervention in both groups. The sonographic grades of fatty liver were not significantly different between two groups before (p=0.94) and after intervention (p=0.93).
In the present clinical trial, L-carnitine did not have significant effect on improving biochemical and sonographic markers of NAFLD in children and adolescents. Future studies are necessary to evaluate the applicability and efficacy of long-term l-carnitine supplementation to treatment of NAFLD in pediatric population.
IRCT20170628034786N2.
非酒精性脂肪性肝病（NAFLD）是全球范围内儿童最常见的肝脏疾病之一。本研究旨在评估左旋肉碱补充剂对儿童和青少年 NAFLD 的影响。
这是一项 2018-2019 年进行的随机、三盲、安慰剂对照临床试验。研究对象为非酒精性脂肪性肝病患者（5-15 岁）。他们被随机分为两组，每天接受 50mg/kg 左旋肉碱两次或相同剂量的安慰剂，持续三个月。干预前后评估肝酶和肝脏超声。两组均接受类似的生活方式改变咨询。
共有 55 名参与者完成了研究，左旋肉碱组 30 名，安慰剂组 25 名。两组的体重指数变化无显著差异（p>0.05）。两组天冬氨酸转氨酶（AST）（p=0.82）和丙氨酸转氨酶（ALT）（p=0.76）水平的平均变化无显著差异。组内分析显示，两组 AST 和 ALT 水平在干预前后均有显著变化。两组治疗前后肝超声脂肪等级无显著差异（p=0.94）。
在本临床试验中，左旋肉碱对改善儿童和青少年非酒精性脂肪性肝病的生化和超声标志物无显著作用。需要进一步研究评估长期左旋肉碱补充对儿科人群非酒精性脂肪性肝病的适用性和疗效。
IRCT20170628034786N2。
