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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00063635
The ClinicalTrials.gov registry entry for NCT00063635 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 20 other Fatty Liver trials with a reported enrollment target (14% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.