| Trial ID: | L0939 |
| Source ID: | NCT01623024
|
| Associated Drug: |
Vitamin D
|
| Title: |
A Randomised Controlled Trial of Vitamin D Plus Plus Lifestyle Versus Lifestyle in Patients With Non-alcoholic Steatohepatitis:Effect on Liver Histology and Metabolic Parameters
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non.Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Vitamin D;Behavioral: Lifestyle counseling
|
| Outcome Measures: |
(a) improvement in NAS by at least 2 points spread across at least 2 of the NAS components or post-treatment NAS of 3 points or less, (b) at least 1 point improvement in the score for ballooning degeneration and (c) no worsening of the fibrosis score.Changes in individual components of NAS score;Changes in intima-media thickness;Changes in liver fibrosis;Changes in insulin resistance
|
| Sponsor/Collaborators: |
University of Palermo
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 3
|
| Enrollment: |
200
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
| Start Date: |
15/06/2012
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 February 2015
|
| Locations: |
Italy
|
| URL: |
http://clinicaltrials.gov/show/NCT01623024
|
