drugset / Trial / NCT02098317

DHA and Vitamin D in Children With Biopsy-proven NAFLD

NCT02098317

Phase 3 Completed 66 enrolled Bambino Gesù Hospital and Research Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression. The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven nonalcoholic fatty liver disease (NAFLD).

Timeline

Start
2014-01
Primary completion
2015-05
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject DOCONEXENT Other / unclassified 500 mg
Subject Vitamin D Other / unclassified 800 iu