Abstract
Objectives
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.
Methods
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.
Results
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).
Conclusions
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.
Trial registration
IRCT20170628034786N2.
Funding source: Isfahan University of Medical Sciences
Award Identifier / Grant number: 397423
Acknowledgments
We thank all participants for their participation in the study.
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Research funding: This study was conducted as the Project number 397423 supported by Isfahan University of Medical Sciences (Research Ethics code:IR.MUI.MED.REC.1397.171).
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Author contributions: Hossein Saneian and Majid Khademian contributed to the conception and design of the research; Motahar Heidari-Beni, Hossein Saneian, Fatemeh Famouri, Peyman Nasri, Leila Khalilian and Majid Khademian collaborated in data collection. Akbar Hassanzadeh and Motahar Heidari-Beni contributed to the acquisition and analysis of the data; Leila Khalilian, Motahar Heidari-Beni, Majid Khademian and Roya Kelishadi drafted the manuscript. All authors critically revised the manuscript, agree to be fully accountable for ensuring the integrity and accuracy of the work, and read and approved the final manuscript. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study. Written informed consent and oral assent were obtained from parents and their children, respectively.
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Ethical approval: Study protocols were reviewed and approved by research and ethics council of the Isfahan University of Medical Sciences, Isfahan, Iran.
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