| Trial ID: | L0321 |
| Source ID: | NCT02098317
|
| Associated Drug: |
Vitamin D
|
| Title: |
DHA and Vitamin D in Children With Biopsy-proven NAFLD
|
| Acronym: |
VitD_DHA
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NAFLD|Non Alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: DHA plus Vitamin D|Drug: Placebo
|
| Outcome Measures: |
Improvement in NAFLD Activity Score (NAS)|improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile|safety
|
| Sponsor/Collaborators: |
Bambino Ges?? Hospital and Research Institute
|
| Gender: |
All
|
| Age: |
4 Years to 16 Years ?? (Child)
|
| Phases: |
Phase 3
|
| Enrollment: |
66
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
January 2014
|
| Completion Date: |
September 2015
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 14, 2016
|
| Locations: |
Bambino Ges?? Children Hospital, Rome, Italy
|
| URL: |
https://ClinicalTrials.gov/show/NCT02098317
|
