Effect on Liver Histology of Vitamin D in Patients With Non-alcoholic Steatohepatitis

Exclusion Criteria

• •1. Average alcohol consumption exceeding 20 g per day in women and 30 g per day in men for at least 3 consecutive months during the previous 5 years, as evaluated by self-administrated questionnaires, 7-day recall tests rand confirmed by a family member.
• •2. Other causes of chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-antitrypsin deficiency (normal serum alpha-1-antitrypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA\<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \<1:160 and absence of histological features of autoimmune hepatitis); HIV infection (anti-HIV negativity); hypo or hyperthyroidism (normal TSH).
• •3. History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention.
• •4. Hepatic cirrhosis with a Child-Pugh score of B or C, and/or concomitant hepatocellular carcinoma
• •5. Recent significant weight loss (\>5% TBW within previous 6 months)
• •6. Recent (within 6 months of baseline liver biopsy and screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens (with the exclusion of standard HRT and oral contraceptive treatment), valproic acid)
• •7. Recent (within 6 months of baseline liver biopsy and screening visit) change in dose/regimen or first treatment with vitamin E, Vitamin C, betaine, s-adenosyl methionine, ursodeoxycholate, sylimarin, fibrate, statin, pentoxyfilline, angiotensin II inhibitors, orlistat, sibutramine. Oral hypoglycaemic agents and insulin will be allowed, provided they had been initiated at least 6 months before enrollment and are maintained at stable doses.
• •8. Ongoing or recent therapy (within 6 months of baseline liver biopsy and screening visit) with vitamin D or with medications known to affect vitamin D3 metabolism, including vitamin/mineral supplements.
• •9. Any additional condition that might interfere with optimal participation in the study, according to Investigators opinion.
• •10. Be pregnant or breastfeeding.