| Trial ID: | L0314 |
| Source ID: | NCT01934777
|
| Associated Drug: |
Vitamin E
|
| Title: |
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Fatty Liver|Liver Fibrosis|Obesity|Metabolic Syndrome|Nonalcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Docosahexaenoic Acid plus Vitamin E plus choline|Drug: placebo pearls
|
| Outcome Measures: |
Improvement in NAFLD Activity Score (NAS)|Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography
|
| Sponsor/Collaborators: |
Bambino Ges?? Hospital and Research Institute
|
| Gender: |
All
|
| Age: |
4 Years to 16 Years ?? (Child)
|
| Phases: |
Phase 3
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
October 2013
|
| Completion Date: |
July 2015
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 14, 2016
|
| Locations: |
Bambino Ges?? Hospital and Research Institute, Rome, Rome, Italy, Italy
|
| URL: |
https://ClinicalTrials.gov/show/NCT01934777
|
