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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00063635 |
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.
Condition | Intervention | Phase |
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Fatty Liver |
Drug: Metformin Dietary Supplement: Vitamin E Drug: Matching placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) |
Estimated Enrollment: | 180 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | September 2009 |
Arms | Assigned Interventions |
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1: Active Comparator
Metformin, 500 mg, twice daily
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Drug: Metformin
500 mg, twice daily
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2: Active Comparator
Vitamin E, 400 IU, twice daily
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Dietary Supplement: Vitamin E
400 IU, twice daily
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3: Placebo Comparator
Matching placebo
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Drug: Matching placebo
Twice daily
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Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92103 | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
United States, Missouri | |
St. Louis University | |
St. Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44109 | |
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Responsible Party: | NIDDK ( Patricia Robuck ) |
Study ID Numbers: | NASH - PEDIATRICS |
Study First Received: | July 1, 2003 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00063635 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non alcoholic fatty liver disease |
Tocopherols Tocopherol acetate Vitamin E Liver Diseases Non-alcoholic Steatohepatitis (NASH) Digestive System Diseases |
Vitamins Metformin Tocotrienols Fatty Liver Alpha-Tocopherol |
Liver Diseases Digestive System Diseases Fatty Liver |