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

NCT01934777 Phase 3 COMPLETED

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).

Details

Lead sponsor	Bambino Gesù Hospital and Research Institute
Phase	Phase 3
Status	COMPLETED
Enrolment	60
Start date	2013-10
Completion	2015-07

Conditions

• Fatty Liver
• Liver Fibrosis
• Obesity
• Metabolic Syndrome
• Nonalcoholic Fatty Liver Disease

Interventions

• Docosahexaenoic Acid plus Vitamin E plus choline
• placebo pearls

Primary outcomes

• Improvement in NAFLD Activity Score (NAS) — 12 months

Countries

Italy