The effect of vitamin D supplementation on liver fibrosis in non-alcoholic fatty liver patients

Phase 2

• Conditions: on-alcoholic fatty liver.; Fatty (change of) liver, not elsewhere classified

• Registration Number: IRCT201405251485N13
• Lead Sponsor: Vice chancellor for Research, Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.