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

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

doi:10.3389/fphar.2023.1149967

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

Front Pharmacol. 2023 Mar 14:14:1149967. doi: 10.3389/fphar.2023.1149967. eCollection 2023.

Authors

Amal Ahmed Mohamed¹, Ahmed Abdel Halim², Sahar Mohamed², Seham Mohamed Mahmoud³, Eman Mohamed Bahgat Eldemiry⁴, Rasha Sobh Mohamed⁵, Mahmoud Maamoun Shaheen⁵, Gina G Naguib⁶, Nashwa M Muharram⁷, Mona G Khalil⁸, Salma Saed⁹, Randa Ibrahim¹⁰, Ahmed Salah Seif¹¹, Noha Kamal¹², Karima Nasraldin¹³, Ali Elsaid Abdelrahman¹⁴, Radwa El Borolossy¹⁵

Affiliations

¹ Department of Biochemistry and Molecular Biology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
² Tropical Medicine Department, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
³ Tropical Medicine Department, El Sahel Teaching Hospital, Cairo, Egypt.
⁴ Fellow of Clinical Pharmacology, Faculty of Pharmacy, Cairo University Hospitals, Cairo, Egypt.
⁵ Internal Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
⁶ Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
⁷ Medical Biochemistry and Molecular Biology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.
⁸ Pharmacology and Toxicology Department, Faculty of Pharmacy, Modern University for Technology and Information, Cairo, Egypt.
⁹ Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
¹⁰ Clinical and Chemical Pathology Department, Nutrition Institute, Cairo, Egypt.
¹¹ Tropical Medicine Hepatology and Gastroenterology Department, Shebeen El-Kom Teaching Hospital, Menoufia, Egypt.
¹² Clinical Pathology Department, Theodor Bilharz Research Institute (TBRI), Ministry of Scientific Research and Higher Education, Gulf Medical University (GMU), Cairo, Egypt.
¹³ Faculty of Biotechnology, Modern Science and Arts University, Cairo, Egypt.
¹⁴ Diagnostic and Intervention Radiology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
¹⁵ Department of Clinical Pharmacy, Faculty of Pharmacy Ain Shams University, Cairo, Egypt.

Abstract

Background and Aim: 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. Subjects and Methods: 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. Results: At the end of the study group 2 revealed significant decrease (p < 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 (p = 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. Conclusion: Cholecalciferol was shown to have beneficial effects on serum ALT levels, hsCRP levels and lipid profile of NAFLD patients. Clinical Trial Registration: https://prsinfo.clinicaltrials.gov/prs-users-guide.html, identifier NCT05613192.

Keywords: Cholecalciferol; Steatosis; hsCRP; lipid profile; non-alcoholic fatty liver.

Associated data

ClinicalTrials.gov/NCT05613192