| Trial ID: | L0986 |
| Source ID: | NCT00063635
|
| Associated Drug: |
Vitamin E
|
| Title: |
Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
|
| Acronym: |
TONIC
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT00063635
|
| Conditions: |
Fatty Liver;Fatty Liver;Fatty Liver;Fatty Liver
|
| Interventions: |
Drug: Metformin;Dietary Supplement: Vitamin E;Drug: Matching placebo;Drug: Metformin;Dietary Supplement: Vitamin E;Drug: Matching placebo;Drug: Metformin;Dietary Supplement: Vitamin E;Drug: Matching placebo;Drug: Metformin;Dietary Supplement: Vitamin E;Dr
|
| Outcome Measures: |
Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L;Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/LChange in Serum Aspartate Aminotransferase (AST);Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment;Number of Participants With Improvement in Liver Fibrosis Score;Number of Participants With Improvement in Steatosis Score;Number of Participants With Improvement in Lobular Inflammation Score;Number of Participants With Improvement in Ballooning Degradation Score;Change in Body Mass Index;Change in Serum Vitamin E Levels;Change in Quality of Life (QOL) Scores- Physical Health;Change in QOL- Psychosocial Health
|
| Sponsor/Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
All
|
| Age: |
8 Years17 Years
|
| Phases: |
Phase 3
|
| Enrollment: |
173
|
| Study Type: |
Interventional
|
| Study Designs: |
--
|
| Start Date: |
01/07/2003
|
| Completion Date: |
--
|
| Results First Posted: |
27/09/2012
|
| Last Update Posted: |
19 October 2017
|
| Locations: |
United States;United States;United States;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00063635
|
