Ebrahimpour-Koujan Soraiya, Sohrabpour Amir Ali, Foroughi Farshad, Alvandi Ehsan, Esmaillzadeh Ahmad
Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.
Trials. 2019 Mar 4;20(1):153. doi: 10.1186/s13063-019-3241-7.
It has been suggested that vitamin D and its receptors involve in suppressing fibrogenic signaling in non-alcoholic fatty liver disease (NAFLD). However, the effect of vitamin D supplementation on fibrogenic factors has not been investigated in NAFLD individuals with steatohepatitis. This study was designed to examine the effects on vitamin D supplementation on serum levels of vitamin D receptor (VDR), fibrogenic factors, and fibrogenic microRNAs (MiR) in NAFLD patients.
Forty-six NAFLD patients will be recruited in this study. After block matching for sex and BMI, they will be randomly assigned to receive 4000 IU/day vitamin D or placebo for 12 weeks. Weight, height, and waist circumference will be measured. Determination of serum fibrogenic MiRs, laminin, collagen type IV, hyaluronic acid, vitamin D, VDR, calcium, blood glucose, serum insulin, lipid profile, liver markers (ALT, AST, total, direct, and indirect bilirubin) will be done at study baseline and at the end of the trial. Insulin resistance and insulin sensitivity will be determined using the HOMA-IR and QUICKI equation.
This is the first randomized controlled trial that will determine the effect of vitamin D supplementation on serum levels of VDR, fibrogenic factors, and fibrogenic MiRs in NAFLD patients. The results of this trial will provide clinical evidence on the effectiveness of vitamin D supplementation in controlling liver fibrosis in NAFLD patients.
Iranian Registry of Clinical Trials, IRCT201405251485N13 . Registered on 14 March 2017.
有研究表明，维生素D及其受体参与抑制非酒精性脂肪性肝病（NAFLD）中的纤维化信号传导。然而，在患有脂肪性肝炎的NAFLD个体中，补充维生素D对纤维化因子的影响尚未得到研究。本研究旨在探讨补充维生素D对NAFLD患者血清维生素D受体（VDR）水平、纤维化因子和纤维化微小RNA（MiR）的影响。
本研究将招募46名NAFLD患者。在按性别和体重指数进行区组匹配后，他们将被随机分配接受4000 IU/天的维生素D或安慰剂，为期12周。测量体重、身高和腰围。在研究基线和试验结束时测定血清纤维化MiR、层粘连蛋白、IV型胶原、透明质酸、维生素D、VDR、钙、血糖、血清胰岛素、血脂谱、肝脏标志物（谷丙转氨酶、谷草转氨酶、总胆红素、直接胆红素和间接胆红素）。使用HOMA-IR和QUICKI方程测定胰岛素抵抗和胰岛素敏感性。
这是第一项随机对照试验，将确定补充维生素D对NAFLD患者血清VDR水平、纤维化因子和纤维化MiR的影响。该试验结果将为补充维生素D在控制NAFLD患者肝纤维化方面的有效性提供临床证据。
伊朗临床试验注册中心，IRCT201405251485N13。于2017年3月14日注册。
