Effectiveness of Inactive Vitamin D Supplementation in Non-Alcoholic Fatty Liver Disease Patients
Non-Alcoholic Fatty Liver Disease
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring non-alcoholic fatty liver- vitamin D
Eligibility Criteria
Inclusion Criteria: patients >18 years with fatty liver diagnosis by using upper abdominal ultrasound echography (US) patients with T2D diagnosed according to ADA 2019 criteria and treated with metformin. Exclusion Criteria: Pregnant and/or lactating women, excessive alcohol use (as defined by an average daily consumption of alcohol > 30 g/day in men and > 20 g/day women), patients with other causes of chronic liver disease as viral hepatitis, drug induced hepatitis, autoimmune hepatitis, patients suffering of chronic kidney disease, hyper/hypoparathyroidism, hypersensitivity to cholecalciferol, hypercalcemia, patients taking supplementation with vitamin D, calcium and medications affecting calcium/vitamin D metabolism (as: anticonvulsants, glucocorticoids, antacids).
Sites / Locations
- National hepatology and tropical medicine research instituteRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Placebo
Cholecalciferol
Group 1: patients receive the standard conventional therapy in addition to placebo for 4 months.
Group 2: patients receive the standard conventional therapy in addition to a single oral dose of cholecalciferol 300,000 IU followed by oral cholecalciferol 800 IU daily for 4 months.