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IRCT201405251485N13 IRCT 2017-03-14 Vice chancellor for Research, Tehran University of Medical Sciences The effect of vitamin D supplementation on liver fibrosis in non-alcoholic fatty liver patients - 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 2017-04-21 anticipated 46 Complete https://irct.ir/trial/772 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -. 2-3 Non-alcoholic fatty liver. Intervention 1: Intervention group will receive daily 1 tablets of vitamin D with meal for 12 weeks. Vitamin D tablets will be purchased from the Pars minoo Company. All the patients will be monitored for consumption of tablets by daily checklists and recall messages. Intervention 2: The control group will receive daily 1 tablets of placebo with meal for 12 weeks. placebo tablets will be purchased from the Pars minoo Company. All the patients will be monitored for consumption of tablets by daily checklists and recall messages.
public Dr. Ahmad Esmaillzadeh
Keshavarz Beulvard, Naderi St, Hojjatdoust alley, No 44 , schools of nutritional sciences and dietetics
Tehran Iran (Islamic Republic of) - +98 21 8895 5569 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences scientific Dr. Ahmad Esmaillzadeh
Keshavarz Beulvard, Naderi St, Hojjatdoust alley, No 44 , schools of nutritional sciences and dietetics
Tehran Iran (Islamic Republic of) - +98 21 8895 5569 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 and tobacco consumption; Pregnancy; lactation; history of viral hepatitis, acute or chronic liver failure; cholestasis; liver transplantation; habitual abuse of nonsteroidal anti-inflammatory drugs; antibiotics; anti-secretory drugs cause achlorhydria within 9 months before the study; Corticosteroids; using hormonal drugs such as estrogen; hereditary hemochromatosis and Wilson disease; alpha-1 antitrypsin deficiency; diabetes; history of heart failure; kidney disease and kidney stones; malignancy or neoplasia; consumption of vitamin D or antioxidants supplements and weight loss during past 3 month; weight loss surgery during past year; being pregnant; consumption of antioxidants supplement; weight loss more than 2 kg during the study; alcohol and tobacco during the study. 20 years 60 years Both K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group will receive daily 1 tablets of vitamin D with meal for 12 weeks. Vitamin D tablets will be purchased from the Pars minoo Company. All the patients will be monitored for consumption of tablets by daily checklists and recall messages. The control group will receive daily 1 tablets of placebo with meal for 12 weeks. placebo tablets will be purchased from the Pars minoo Company. All the patients will be monitored for consumption of tablets by daily checklists and recall messages. Hyaluronic acid. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. Laminin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. Collagen type 4. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. Vitamin D receptor. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. MiR-122. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Real-time PCR. MiR-34a. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Real-time PCR. MiR-21. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Real-time PCR. AST. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. PTH. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. Nutritional status (calorie and nutrients intake). Timepoint: Every 2 weeks during the intervention. Method of measurement: Food record questionnaire. Anthropometric index(weight, height,WHR and Body Mass Index). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Analogue scale for weight, height, WHR and weight(Kg)/Square Height for body mass index. Physical activity. Timepoint: Every 2 weeks during the intervention. Method of measurement: International Physical Activity questionnaire. Fasting blood glucose. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic colorimetric. Fasting insulin serum. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: HOMA-IR calculation. Insulin sensitivity. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: QUICKI calculation. Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5). ALT. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay. Vice chancellor for Research, Tehran University of Medical Sciences Approved 2017-02-08 Ethics committee of Tehran University of Medical Sciences Keshavarz blv., Ghods st. Tehran Iran (Islamic Republic of)