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
Department of Biochemistry and Molecular Biology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
Tropical Medicine Department, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
Front Pharmacol. 2023 Mar 14;14:1149967. doi: 10.3389/fphar.2023.1149967. eCollection 2023.
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. 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. At the end of the study group 2 revealed significant decrease ( < 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 ( = 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. Cholecalciferol was shown to have beneficial effects on serum ALT levels, hsCRP levels and lipid profile of NAFLD patients. https://prsinfo.clinicaltrials.gov/prs-users-guide.html, identifier NCT05613192.
非酒精性脂肪性肝病（NAFLD）是全球最常见的进行性代谢紊乱疾病之一。目前，维生素D状态与非酒精性脂肪性肝病之间的关联引发了越来越多的科学关注。早期研究表明，非酒精性脂肪性肝病患者中维生素D缺乏非常普遍，这会导致不良后果。因此，本研究旨在评估口服胆钙化醇对非酒精性脂肪性肝病患者的疗效和安全性。本研究对140名患者进行，在为期4个月的研究期间，这些患者被随机分为两组，第1组除接受安慰剂外还接受标准常规治疗，第2组除接受标准常规治疗外还接受胆钙化醇治疗。研究结束时，与基线结果和第1组结果相比，第2组的甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）、总胆固醇（TC）、高敏C反应蛋白（hsCRP）平均血清水平显著降低（<0.05）。此外，研究结束时，与第1组相比，第2组的谷丙转氨酶（ALT）血清水平有显著改善（P = 0.001）。而与第2组及其基线结果相比，第1组在这些参数上没有任何变化。胆钙化醇对非酒精性脂肪性肝病患者的血清ALT水平、hsCRP水平和血脂谱有有益影响。https://prsinfo.clinicaltrials.gov/prs-users-guide.html，标识符NCT05613192 。
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