Skip to main content
OpenTrials
Completed

NCT Number: NCT02842567

Hydroxytyrosol and Vitamin E in Pediatric NASH

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hepatometabolic Department, Bambino Gesù Children's Hospital

Rome, 00165, Italy

About this study

80 children and adolescents (4-16 years) with biopsy-proven NASH will be enrolled. They will be randomized to treatment with hydroxytyrosol and vitamin E (n: 40 pts) or an identical placebo (n: 40 pts) given orally for a period of 16 weeks. Patients will undergo a medical evaluation at baseline (enrollment) and after 4 months (end of treatment). Anthropometric measures and laboratory assay, includin liver enzymes, gluco-insulinemic and lipid profiles will be performed at baseline and at the end of the study. Hepatic ultrasound examination will be performed at enrollment and at the end of the study.

Serum sample for determination of markers of inflammation and oxidative stress will be collected at enrollment and at the end of the study.

A stool sample for analysis of gut microbioma will be collected at enrollment and at the end of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver biopsy consistent with diagnosis of NASH (liver biopsy performed in 3-6 months before enrollment)
  • Hyperechogenicity of liver at ultrasound examination
  • ALT levels range between normal and < 10 UNL
  • INR < 1.3
  • Albumin > 3 gr/dl.
  • Total bilirubin < 2.5 mg/dl
  • normal renal function
  • normal cells blood count
  • exclusion of other causes of chronic hepatopathies in children
  • Written informed consent to participate in the Protocol by their parents or legal guardians of patients

Exclusion criteria

  • alcohols or drugs abuse
  • use of drugs known to induce steatosis or to affect body weight or carbohydrate metabolism
  • autoimmune liver diseases, Wilson's disease, alpha-1-antitripsin deficiency, metabolic liver disease
  • every clinical or psychiatric diseases interfering with experimentation according to investigator's evaluation
  • finding of active liver disease due to other causes

Treatment and study plan

Hydroxytyrosol plus Vitamin E

Drug

This group will treated with 2 pills daily, each containing 3.75 mg of hydroxytyrosol plus 5 mg of Vitamin E, given orally for 16 weeks

Other names: Hydroxytyrosol, alpha-tocopherol

Placebo

Drug

This group will treated with 2 identical placebo pills daily given orally for 16 weeks.

Primary outcomes

  1. Improvement of laboratory markers of inflammation and oxidative stress, such as concentrations of TNF-alpha, lipopolysaccharide (LPS), adiponectin, catepsin D, cytokeratin-18.

    Time frame: 4 months

  2. Improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile, transaminases serum levels

    Time frame: 4 months

Secondary outcomes

  1. Improvement of echographic score of hepatic steatosis (echographic scale)

    Time frame: 4 months

  2. Number of participants with treatment-related adverse events as assessed by CTCAE

    Time frame: 4 months

  3. Analysis of fecal gut microbiome of patients before and after treatment with hydroxytyrosol and vitamin E

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

Hydroxytyrosol and Vitamin E in the Treatment of Children With Biopsy-proven NASH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 25, 2016
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.