Non-alcoholic fatty liver. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
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
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
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 t
Sponsors
Vice chancellor for Research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion 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 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Ahmad Esmaillzadeh
Tehran University of Medical Sciences
Outcome results
None listed