| Trial ID: | L0968 |
| Source ID: | NCT00885313
|
| Associated Drug: |
DHA
|
| Title: |
Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).
|
| Acronym: |
EDACN
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Fatty Liver;Liver Fibrosis;Obesity;Metabolic Syndrome;Nonalcoholic Fatty Liver Disease
|
| Interventions: |
Drug: DHA250;Drug: DHA500;Drug: PLACEBO;Behavioral: Lifestyle intervention
|
| Outcome Measures: |
Liver status by liver biopsy (steatosis and fibrosis)Serum alanine transferase levels;Serum levels of triglycerides
|
| Sponsor/Collaborators: |
Bambino Ges?? Hospital and Research Institute
|
| Gender: |
All
|
| Age: |
4 Years16 Years
|
| Phases: |
Phase 1/Phase 2
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
|
| Start Date: |
20/04/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 February 2015
|
| Locations: |
Italy
|
| URL: |
http://clinicaltrials.gov/show/NCT00885313
|
