Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents: the TONIC randomized controlled trial.

ABSTRACT:

Context

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in US children and adolescents and can present with advanced fibrosis or nonalcoholic steatohepatitis (NASH). No treatment has been established.

Objective

To determine whether children with NAFLD would improve from therapeutic intervention with vitamin E or metformin.

Design, setting, and patients

Randomized, double-blind, double-dummy, placebo-controlled clinical trial conducted at 10 university clinical research centers in 173 patients (aged 8-17 years) with biopsy-confirmed NAFLD conducted between September 2005 and March 2010. Interventions Daily dosing of 800 IU of vitamin E (58 patients), 1000 mg of metformin (57 patients), or placebo (58 patients) for 96 weeks.

Main out

SUBMITTER: Lavine JE 

PROVIDER: S-EPMC3110082 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature