Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT05613192
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05613192
Study Brief:
Protocol Section:
NCT05613192