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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
173
500 mg, twice daily
400 IU, twice daily
Twice daily
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 D.C., District of Columbia, United States
Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L
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.
Time frame: baseline and 96 weeks
Change in Serum Aspartate Aminotransferase (AST)
Time frame: baseline and 96 weeks
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
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).
Time frame: baseline and 96 weeks
Number of Participants With Improvement in Liver Fibrosis Score
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.
Time frame: baseline and 96 weeks
Number of Participants With Improvement in Steatosis Score
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.
Time frame: baseline and 96 weeks
Number of Participants With Improvement in Lobular Inflammation Score
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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
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.
Time frame: baseline and 96 weeks
Number of Participants With Improvement in Ballooning Degradation Score
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.
Time frame: baseline and 96 weeks
Change in Body Mass Index
Time frame: baseline and 96 weeks
Change in Serum Vitamin E Levels
Change in alpha-Tocopherol
Time frame: baseline and 96 weeks
Change in Quality of Life (QOL) Scores- Physical Health
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.
Time frame: baseline and 96 weeks
Change in QOL- Psychosocial Health
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.
Time frame: baseline and 96 weeks