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Recruiting
NCT05613192
Effectiveness of Inactive Vitamin D Supplementation in Non-Alcoholic Fatty Liver Disease Patients
Conditions: Non-Alcoholic Fatty Liver Disease
Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE3
Enrollment: 100
Sponsor: Ain Shams University
Location: Egypt
Summary
Aim of work The aim of our study is to assess the effectiveness and safety of high oral loading dose of inactive vitamin D supplementation on the clinical parameters related to liver steatosis, glycaemic control, insulin resistance and metabolic profile in NAFLD patients
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).
Source: ClinicalTrials.gov (NCT05613192). StuddyBuddy aggregates publicly available trial information.