| Trial ID: | L0658 |
| Source ID: | EUCTR2011-003010-17-IT
|
| Associated Drug: |
Vitamin D
|
| Title: |
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 dise
|
| Acronym: |
--
|
| Status: |
Authorised
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Patients affected by type 2 diabetes and non alcoholic fatty liver disease- non alcoholic steato-hepatitis (NAFLD/NASH) <br>MedDRA version: 14.1
Level: SOC
Classification code 10027433
Term: Metabolism and nutrition disorders
System Organ Class: 10027433
|
| Interventions: |
<br>Trade Name: DIBASE*OS GTT 10ML 10000UI/ML<br>Pharmaceutical Form: Oral drops, solution<br>INN or Proposed INN: NA<br>CAS Number: NA<br>Current Sponsor code: NA<br>Other descriptive name: NA<br>Concentration unit: U unit(s)<br>Concentration type: up to
|
| Outcome Measures: |
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 monthsSecondary 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
|
| Sponsor/Collaborators: |
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
--
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
|
| Start Date: |
07/03/2012
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 April 2012
|
| Locations: |
Italy
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003010-17
|
