TREATMENT OF NONALCOHOLIC LIVER DISEASE IN CHILDREN (TONIC)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter, masked, placebo-controlled, randomized clinical trial designed to determine whether 96 weeks of treatment with either metformin or vitamin E leads to sustained reduction in serum ALT in nondiabetic children with NAFLD compared to treatment with placebo. There can be up to 16 weeks of screening prior to randomization, a 96-week treatment phase, and then a 24-week post-treatment follow-up phase. A total of 180 patients in 3 groups of equal size (60 per group: metformin, vitamin E, placebo) will be enrolled from 9 pediatric sites.