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 to non-alcoholic steatohepatitis (NASH).
Hydroxytyrosol is a simple phenolic compound naturally occurring in olive and olive oil with
antioxidant properties. Some studies have demonstrated that hydroxytyrosol show several
anti-inflammatory and anti-atherogenic activities, such as the inhibition of LDL oxidation
and platelet aggregation.
Alpha tocopherol (Vitamin E) is the most studied anti-oxydant in pediatric NAFLD with
conflicting results. It inhibits proinflammatory cytokine production and attenuates the
release of profibrogenic agents and liver collagen.
The purpose of this interventional study is to evaluate the efficacy and tolerability of
Hydroxytyrosol and Vitamin E in the treatment of children with biopsy-proven NASH.
Phase:
Phase 3
Details
Lead Sponsor:
Bambino Gesù Hospital and Research Institute
Treatments:
3,4-dihydroxyphenylethanol alpha-Tocopherol Phenylethyl Alcohol Tocopherols Tocotrienols Vitamin E Vitamins