Hepat Mon. 2019 July; 19(7):e86719. Published online 2019 August 3. doi: 10.5812/hepatmon.86719. Research Article Alleviating Effects of Ursodeoxycholic Acid in Children with Acute Hepatitis A Infection: A Randomized Clinical Trial Kaveh Tabrizian 1 , Iraj Shahramian 2, * , Ali Bazi 3 , Mahdi Afshari 4 and Asma Ghaemi 5 1 Department of Pharmacology, Zabol University of Medical Sciences, Zabol, Iran 2 Department of Pediatrics, Zabol University of Medical Sciences, Zabol, Iran 3 Department of Hematology, Zabol University of Medical Sciences, Zabol, Iran 4 Department of Community Medicine, Zabol University of Medical Sciences, Zabol, Iran 5 Student Research Committee, Zabol University of Medical Sciences, Zabol, Iran * Corresponding author: Pediatric Ward, Amir-Al-Momenin Hospital, Zabol, Iran. Email: ir_buper@yahoo.com Received 2018 November 24; Revised 2019 July 03; Accepted 2019 July 23. Abstract Objectives: Ursodeoxycholic acid (UDCA) is a secondary hydrophilic bile acid with alleviating effects on liver enzymes. This study aimed to investigate the effect of UDCA on the improvement of liver enzymes in children with hepatitis A infection. Methods: In this randomized clinical trial, 152 patients were randomly allocated to either intervention (UDCA) or control (no drug) group. Liver enzymes were measured six times within six months post-therapy. Statistical tests were carried out using SPSS 19 soft- ware. Results: The mean ALT level reduced from 1296.7 ± 1236 IU/L to 15.4 ± 3 IU/L in the UDCA group after six months. ALT also reduced from 1062.3 ± 959 IU/L to 16.4 ± 5 IU/L in the control group. The ratio of patients with normal ALT levels was significantly higher in the UDCA group (n = 61, 80.3%) than in the control group (n = 51, 68%) two months post-therapy (P = 0.06). The mean level of AST reduced from 983.8 ± 1036 IU/L to 19.4 ± 5 IU/L in the UDCA group and from 981.8 ± 1177 IU/L to 22.8 ± 7 IU/L in the control group. The ratio of patients with normal AST levels was significantly higher in the UDCA group than in the control group one month (n = 34, 44.7% vs. n = 20, 26.7%, respectively; P = 0.02), two months (n = 51, 67.1% vs. n = 31, 41.3%, respectively; P = 0.001), and three months (n = 66, 86.8% vs. n = 56, 74.7%, respectively; P = 0.04) post-therapy. Six months post-therapy, all the patients reached normal AST and ALT levels in both groups. Conclusions: Our results indicated that UDCA accelerated achieving biochemical response in children with acute hepatitis A. Keywords: UDCA, D-Alanine Transaminase, Aspartate Aminotransferases, Hepatitis A, Pediatrics 1. Background Hepatitis A virus (HAV) belongs to the picornavirus family and causes liver dysfunction in a considerable ratio of populations (1). HAV infection is transmitted through the oral-fecal route. HAV can lead to widespread epidemics and mortality in adults, especially in societies with poor health conditions; nevertheless, the mortality and morbid- ity rates are low in pediatrics (2). This disease is usually self-limiting. A small ratio of patients with HAV shows the recurrence of hepatitis from weeks to months after initial improvement. The recur- rence is usually associated with increased aminotrans- ferases and jaundice. Uncommonly, HAV may present as cholesteric and fulminant hepatitis that is characterized by prolonged cholestatic jaundice and itching (3, 4). The diagnosis of HAV is made by serological tests and biochemical evaluation of liver function. The acute HAV in- fection is characterized by increased levels of AST and ALT due to prominent damage to hepatocytes. The maximum levels of these enzymes usually reach during the icteric phase of the disease while the enzymes gradually decrease during the recovery phase (5, 6). Ursodeoxycholic acid (UDCA) is a secondary dihydro- folic dihydroxy bile acid with hydrophilic properties (7). UDCA has been used to treat many diseases including biliary cirrhosis, primary sclerosing cholangitis, cystic fi- brosis, and non-alcoholic fatty liver disease (8). UDCA has shown to reduce serum bilirubin, ALT, AST, ALP, and gamma-glutamyl transpeptidase (GGT), especially in cholestatic patients such as those with primary biliary cir- rhosis (PBC) and scleral cholangitis (9). This drug also im- proves cholesteric and cytologic parameters in patients with chronic liver diseases such as chronic hepatitis and cystic fibrosis (10). UDCA has also been used as a comple- Copyright © 2019, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.