Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
- Conditions
- Fatty Liver
- Interventions
- Registration Number
- NCT00063635
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Matching placebo Matching placebo 2 Vitamin E Vitamin E, 400 IU, twice daily 1 Metformin Metformin, 500 mg, twice daily
- Primary Outcome Measures
Name Time Method Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L baseline and 96 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment baseline and 96 weeks Histological activity was assessed using the NAFLD activity score on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (0-3), lobular inflammation (0-3), and hepatocellular ballooning (0-2).
Number of Participants With Improvement in Ballooning Degradation Score baseline and 96 weeks Ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe ballooning. This secondary outcome measure is the number of participants that experienced a decrease in ballooning score at 96 weeks compared to baseline, which indicates improvement in ballooning.
Number of Participants With Improvement in Steatosis Score baseline and 96 weeks Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score at 96 weeks compared to baseline, which indicates improvement in steatosis.
Number of Participants With Improvement in Lobular Inflammation Score baseline and 96 weeks Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score at 96 weeks compared to baseline, which indicates improvement in lobular inflammation.
Change in Body Mass Index baseline and 96 weeks Change in Serum Vitamin E Levels baseline and 96 weeks Change in alpha-Tocopherol
Number of Participants With Improvement in Liver Fibrosis Score baseline and 96 weeks Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score at 96 weeks compared to baseline, which indicates improvement in fibrosis.
Change in Serum Aspartate Aminotransferase (AST) baseline and 96 weeks Change in Quality of Life (QOL) Scores- Physical Health baseline and 96 weeks Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.
Change in QOL- Psychosocial Health baseline and 96 weeks Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.
Related Research Topics
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Trial Locations
- Locations (10)
University of California, San Diego
🇺🇸San Diego, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of California, San Diego🇺🇸San Diego, California, United States