| Trial ID: | L0124 |
| Source ID: | NCT00694746
|
| Associated Drug: |
Fish Oil
|
| Title: |
Study of Fish Oil to Reduce ALT Levels in Adolescents
|
| Acronym: |
--
|
| Status: |
Terminated
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease|Fatty Liver
|
| Interventions: |
Drug: Omega-3-acid ethyl esters|Drug: Placebo
|
| Outcome Measures: |
Efficacy parameters: Characterize the reduction in ALT levels.|Safety/compliance parameters: Describe the safety blood tests results, review of systems, and physical examination at baseline, mid point, and end of treatment, as well as identify adverse events and compliance parameters at study contacts.|Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.
|
| Sponsor/Collaborators: |
Boston University|GlaxoSmithKline
|
| Gender: |
All
|
| Age: |
13 Years to 17 Years ?? (Child)
|
| Phases: |
Phase 1
|
| Enrollment: |
3
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
June 2008
|
| Completion Date: |
March 2014
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 29, 2016
|
| Locations: |
Boston University Medical Center, Boston, Massachusetts, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT00694746
|
