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首页> 外文期刊>Trials >Effects of vitamin D supplementation on liver fibrogenic factors in non-alcoholic fatty liver patients with steatohepatitis: study protocol for a randomized clinical trial
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Effects of vitamin D supplementation on liver fibrogenic factors in non-alcoholic fatty liver patients with steatohepatitis: study protocol for a randomized clinical trial

机译：补充维生素D对非酒精性脂肪肝合并脂肪性肝炎患者肝纤维化因子的影响：一项随机临床试验的研究方案

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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.
机译：已经提出维生素D及其受体参与抑制非酒精性脂肪肝疾病（NAFLD）中的纤维化信号传导。但是，尚未在患有脂肪性肝炎的NAFLD患者中研究补充维生素D对纤维化因子的作用。这项研究旨在检查补充维生素D对NAFLD患者血清维生素D受体（VDR），纤维化因子和纤维化微RNA（MiR）的影响。本研究将招募46名NAFLD患者。在按性别和BMI进行分组匹配后，他们将被随机分配接受4000 IU /天的维生素D或安慰剂，持续12周。将测量体重，身高和腰围。血清纤维化MiRs，层粘连蛋白，IV型胶原蛋白，透明质酸，维生素D，VDR，钙，血糖，血清胰岛素，脂质谱，肝标志物（ALT，AST，总，直接和间接胆红素）的测定在研究基线和试验结束时。胰岛素抵抗和胰岛素敏感性将使用HOMA-IR和QUICKI方程确定。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，纤维化因子和纤维化MiR的影响。该试验的结果将为补充维生素D控制NAFLD患者肝纤维化的有效性提供临床证据。伊朗临床试验注册中心IRCT201405251485N13。 2017年3月14日注册。

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