Trials / Completed
CompletedNCT00063635
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 173 (actual)
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
- Sex
- All
- Age
- 8 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metformin | 500 mg, twice daily |
| DIETARY_SUPPLEMENT | Vitamin E | 400 IU, twice daily |
| DRUG | Matching placebo | Twice daily |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2009-09-01
- Completion
- 2010-02-01
- First posted
- 2003-07-03
- Last updated
- 2012-09-27
- Results posted
- 2012-09-27
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00063635. Inclusion in this directory is not an endorsement.