The effect of vitamin D supplementation on serum concentrations of fibrogenic factors, vitamin D receptor and liver-related micro-RNAs in non-alcoholic fatty liver patients

(1) Objectives: In this study NAFLD patients will be assessed in order to determine the effects effect of vitamin D supplementation on serum concentrations of fibrogenic factors, vitamin D receptor and liver-related micro-RNAs. (2) Design: This study will be conducted as a randomized controlled trial. (3) Setting and conduct: Subjects were randomly divided into two groups including 23 subjects (taking vitamin D supplement) and control (placebo). For each patient anthropometric measurements (height, weight and waist circumference) and general characteristics will be assessed at the baseline and end of the study will be filled. 24-h food record questionnaire in order to assessment of food intake and physical activity questionnaire will be complete every two week during the trial. 10 cc fasting blood samples from each patient will be taken at the beginning and end of the intervention. (4) Participants including major eligibility criteria: Inclusion criteria consists of: age between 20 and 60 years old; non- alcoholic fatty liver disease diagnosed by a radiologist and hepatologist using ultrasonography into one of three categories (grade 2 or 3); vitamin D deficiency or insufficiency and Exclusion criteria are: alcohol consumption, history of viral hepatitis; acute or chronic liver failure; malignancy; habitual abuse of nonsteroidal anti-inflammatory drugs; antibiotics; Corticosteroids; … (5) Intervention: Intervention groups will receive daily 1 vitamin D tablets containing 4000 IU vitamin D with meal and control group use the same placebo tablets daily for 12 weeks. (6) Main outcome measures (variables): Serum collagen type 4, laminin, hyaluronic acid, vitamin D receptor, MiR-122, MiR-34a and MiR-21 in both groups before and after the intervention will be measured.

Vice chancellor for Research, Tehran University of Medical Sciences