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NCT00063635 · ClinicalTrials.gov registry record · Phase 3
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
A Phase 3 study of Fatty Liver, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
- 10
- Study locations
NCT00063635: Completed Phase 3 study of Fatty Liver, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00063635 is a Phase 3 study of Fatty Liver that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 173 participants, below the 202-participant average among 20 other Fatty Liver trials with a reported enrollment target (14% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00063635, a Phase 3 study of Fatty Liver, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
The primary outcome was sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 IU/L or less at each visit from 48 to 96 weeks of treatment.
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG Metformin
- DIETARY_SUPPLEMENT Vitamin E
Study Locations (10)
California
- University of California, San Diego - San Diego
- University of California, San Francisco - San Francisco
District of Columbia
- Children's National Medical Center - Washington D.C.
Indiana
- Indiana University - Indianapolis
Maryland
- Johns Hopkins University - Baltimore
Missouri
- St. Louis University - St Louis
Ohio
- Case Western Reserve University - Cleveland
Texas
- Texas Children's Hospital - Houston
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2005-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
What the finished NCT00063635 record still lists
NCT00063635 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 202-participant average among 20 other Fatty Liver trials with a reported enrollment target (14% lower).
The record links to 1 condition, with Fatty Liver appearing as the primary indexed condition, and to 3 interventions - of which Matching placebo is the first listed.
NCT00063635 lists 10 locations in 9 states (California, District of Columbia, Indiana).
Frequently Asked Questions
What is clinical trial NCT00063635 about?
NCT00063635 is a clinical study titled "Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)". 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.
What is the current status of trial NCT00063635?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2005-09. Estimated completion is 2010-02.
What conditions does trial NCT00063635 study?
This clinical trial studies the following conditions: Fatty Liver.
What interventions are being tested in trial NCT00063635?
The interventions under investigation include: Matching placebo (DRUG), Metformin (DRUG), Vitamin E (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00063635?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00063635 being conducted?
This trial has 10 study locations across California, District of Columbia, Indiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fatty Liver
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00063635's enrollment target sits among peer trials
173 6th of 20 higher than 15 of 20 other Fatty Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fatty Liver trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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