drugset / Trial / NCT01934777

Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

NCT01934777

Phase 3 Completed 60 enrolled Bambino Gesù Hospital and Research Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

Timeline

Start
2013-10
Primary completion
2014-10
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Choline Other / unclassified 201 mg Oral
Subject DOCONEXENT Other / unclassified 250 mg Oral
Subject Vitamin E Other / unclassified 39 iu Oral