At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 173 enrolled
Drug / intervention
Metformin +2 moredrug
Likely dose
Metformin 500 mg orally twice daily OR Vitamin E 400 IU twice dailyAI-extracted
Key inclusion· 4
- ✓Age 8–17 years at first screening visit
- ✓Histologic evidence of NAFLD confirmed by liver biopsy within 6 months of randomization
- ✓ALT >60 U/L at screening visit
- ✓ALT >60 U/L documented on at least one prior occasion 1–6 months before screening
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Jul 3, 2003·Updated Sep 27, 2012
In Brief
A Phase 3 clinical trial evaluating Metformin, Vitamin E, and 1 other intervention for Fatty Liver. Completed, enrolled 173 participants across 10 sites.
Detailed Summary
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatty Liver
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2003
Enrollment StartSep 2005
Primary CompletionSep 2009
Study CompletionFeb 2010
TodayJul 2026
First PostedJul 3, 2003
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 23.0 years ago
Interventions
Metformindrug
500 mg, twice daily
Vitamin Edietary
400 IU, twice daily
Matching placebodrug
Twice daily