Randomized double-blind intervention trial to assess the efficacy of vitamin D3 supplementation vs placebo in reducing hepatic steato-inflammation and cardio-metabolic risk profile in patients affected by type 2 diabetes and non-alcoholic fatty liver disease (NAFLD/NASH)

Conditions: Patients affected by type 2 diabetes and non alcoholic fatty liver disease- non alcoholic steato-hepatitis (NAFLD/NASH)
MedDRA version: 14.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-003010-17-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Aged between 25 and 65 years
Diagnosis of Type 2 Diabetes Mellitus
Presence of ultrasound detected fatty liver confirmed by MRI
acceptance of informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

e <25 or> 65 years
History of alcohol abuse (> 40 mg / day for men,> 20 mg / day for women)
Acute or chronic liver infections autoimmune hepatitis
History of cancer
Other causes of liver disease (hemochromatosis, Wilson's disease)
renal failure
Hyper / hypoparathyroidism
chronic enteropathies
Hypersensitivity to any of the excipients or cholecalciferol hypercalcemia, hypercalciuria (nephrolithiasis, nephrocalcinosis) Therapy with vitamin D, calcium or other drugs affecting bone metabolism, calcium and vitamin D metabolism (anticonvulsants, glucocorticoids, antacids containing aluminum, cholestyramine ) Pregnancy and lactation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of oral supplementation with cholecalciferol in improving liver steato-inflammation in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH.;Secondary Objective: To evaluate the efficacy of oral supplementation with cholecalciferol in improving cardio-metabolic risk profile (insulin-sensitivity, lipids, sistemic inflammation, glucose tolerance, body fat distribution) in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH.;Primary end point(s): Reduction of hepatic steatosis in patients with NAFLD and reduction in steatosis, inflammation and liver fibrosis in patients with NASH treated with Vitamin D oral supplementation;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary objective of this study is to assess changes in the cardio-metabolic risk profile in diabetic patients treated with Vitamin D oral supplementation;Timepoint(s) of evaluation of this end point: 12 months