AUTHOR=Mohamed Amal Ahmed , Halim Ahmed Abdel , Mohamed Sahar , Mahmoud Seham Mohamed , Bahgat Eldemiry Eman Mohamed , Mohamed Rasha Sobh , Shaheen Mahmoud Maamoun , Naguib Gina G. , Muharram Nashwa M. , Khalil Mona G. , Saed Salma , Ibrahim Randa , Salah Seif Ahmed , Kamal Noha , Nasraldin Karima , Abdelrahman Ali Elsaid , El Borolossy Radwa 

TITLE=The effect of high oral loading dose of cholecalciferol in non-alcoholic fatty liver disease patients. A randomized placebo controlled trial

JOURNAL=Frontiers in Pharmacology

VOLUME=14

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1149967

DOI=10.3389/fphar.2023.1149967

ISSN=1663-9812

ABSTRACT=<p><bold>Background and Aim:</bold> Non-alcoholic fatty liver (NAFLD) is one of the most common progressive metabolic disorders worldwide. There are increasing scientific interests nowadays for the association between vitamin D status and Non-alcoholic fatty liver. Earlier studies have revealed that vitamin D deficiency is highly prevalent in Non-alcoholic fatty liver patients that contributes to poor outcomes. Hence, the present study aimed to assess the efficacy and safety of oral cholecalciferol on Non-alcoholic fatty liver patients.</p><p><bold>Subjects and Methods:</bold> This study was conducted on 140 patients that were randomized either to group 1 that received the standard conventional therapy in addition to placebo or group 2 that received the standard conventional therapy in addition to cholecalciferol during the 4 months study period.</p><p><bold>Results:</bold> At the end of the study group 2 revealed significant decrease (<italic>p</italic> &lt; 0.05) in the mean serum level of TG, LDL-C, TC, hsCRP as compared to their baseline results and group 1 results. Additionally, a significant improvement in the serum levels of ALT (<italic>p</italic> = 0.001) was seen in group 2 at the end of the study when compared to group 1. Whereas group 1 did not show any change in these parameters when compared to group 2 and their baseline results.</p><p><bold>Conclusion:</bold> Cholecalciferol was shown to have beneficial effects on serum ALT levels, hsCRP levels and lipid profile of NAFLD patients.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="https://prsinfo.clinicaltrials.gov/prs-users-guide.html" xmlns:xlink="http://www.w3.org/1999/xlink">https://prsinfo.clinicaltrials.gov/prs-users-guide.html</ext-link>, identifier NCT05613192</p>