Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Internal Medicine, School of Medicine, Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Clin Nutr. 2021 May;40(5):2999-3005. doi: 10.1016/j.clnu.2020.11.037. Epub 2020 Dec 8.
BACKGROUND & AIMS: Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in the world with no definite treatment. Insulin resistance (IR) and low serum vitamin D are closely linked to NAFLD. Since there is no comparative study on the effect of calcitriol with cholecalciferol on NAFLD based on homeostasis model of insulin resistance (HOMA-IR) as an IR indicator, so we designed this research.
A double blind randomized clinical trial was conducted on patients with NAFLD with concomitant vitamin D deficiency/insufficiency at two referral tertiary teaching medical centers, from July 2017 to January 2019. Patients were randomly divided into two groups: calcitriol (1 mcg/day) and cholecalciferol (50,000 IU/week) for 8 weeks. Before and after the intervention, anthropometric and laboratory data were measured and HOMA-IR was calculated for each patient.
54 patients completed the trial. In total, calcitriol supplementation improved serum insulin levels as well as IR based on the HOMA-IR index, significantly compared to the cholecalciferol group. HOMA-IR decreased 1.8 times more in patients receiving calcitriol than in those receiving cholecalciferol, which was clinically meaningful. The observed changes were more pronounced in patients with higher baseline body mass index. Moreover, calcitriol was more associated with a significant decrease in liver enzymes and cholesterol levels comparing to cholecalciferol.
Based on the findings of this study, the use of calcitriol supplementation significantly reduced HOMA-IR as an IR indicator in NAFLD patients, compared to cholecalciferol. To confirm this findings, further studies with larger sample sizes are recommended.
非酒精性脂肪性肝病(NAFLD)是世界上最常见的肝脏疾病,目前尚无明确的治疗方法。胰岛素抵抗(IR)和血清维生素 D 水平低与 NAFLD 密切相关。由于尚无基于胰岛素抵抗稳态模型(HOMA-IR)作为 IR 指标的比较研究评估骨化三醇与胆钙化醇对 NAFLD 的影响,因此我们进行了这项研究。
在 2017 年 7 月至 2019 年 1 月期间,在两家转诊的三级教学医疗中心对伴有维生素 D 缺乏/不足的 NAFLD 患者进行了一项双盲随机临床试验。患者被随机分为两组:骨化三醇(1 mcg/天)和胆钙化醇(50,000 IU/周),干预 8 周。在干预前后,测量了患者的人体测量学和实验室数据,并计算了 HOMA-IR。
54 例患者完成了试验。与胆钙化醇组相比,骨化三醇补充剂显著改善了血清胰岛素水平和 HOMA-IR 指数所反映的 IR。与接受胆钙化醇的患者相比,接受骨化三醇的患者的 HOMA-IR 降低了 1.8 倍,这具有临床意义。在基线体重指数较高的患者中,观察到的变化更为明显。此外,与胆钙化醇相比,骨化三醇与肝酶和胆固醇水平的显著降低更为相关。
基于本研究的结果,与胆钙化醇相比,骨化三醇补充剂可显著降低 NAFLD 患者的 HOMA-IR,作为 IR 指标。为了证实这一发现,建议进行更大样本量的进一步研究。