| Trial ID: | L0577 |
| Source ID: | NCT02842567
|
| Associated Drug: |
Vitamin E
|
| Title: |
Hydroxytyrosol and Vitamin E in the Treatment of Children With Biopsy-proven NASH
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD
|
| Interventions: |
Drug: Hydroxytyrosol plus Vitamin E;Drug: Placebo
|
| Outcome Measures: |
Improvement of laboratory markers of inflammation and oxidative stress, such as concentrations of TNF-alpha, lipopolysaccharide (LPS), adiponectin, catepsin D, cytokeratin-18.;Improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile, transaminases serum levelsImprovement of echographic score of hepatic steatosis (echographic scale);Number of participants with treatment-related adverse events as assessed by CTCAE;Analysis of fecal gut microbiome of patients before and after treatment with hydroxytyrosol and vitamin E
|
| Sponsor/Collaborators: |
Bambino Ges?? Hospital and Research Institute
|
| Gender: |
All
|
| Age: |
4 Years16 Years
|
| Phases: |
Phase 3
|
| Enrollment: |
80
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
13/07/2016
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT02842567
|
