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Trial record 2 of 15 for:    hydroxytyrosol

Hydroxytyrosol and Vitamin E in Pediatric NASH

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ClinicalTrials.gov Identifier: NCT02842567
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute

Brief 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 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.


Condition or disease Intervention/treatment Phase
NAFLD Drug: Hydroxytyrosol plus Vitamin E Drug: Placebo Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydroxytyrosol and Vitamin E in the Treatment of Children With Biopsy-proven NASH
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018


Arm Intervention/treatment
Experimental: TREATED GROUP
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.
Drug: Hydroxytyrosol plus Vitamin E
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 Name: Hydroxytyrosol, alpha-tocopherol

Placebo Comparator: PLACEBO GROUP
This group will treated with 2 identical placebo pills daily given orally for 16 weeks.
Drug: Placebo
This group will treated with 2 identical placebo pills daily given orally for 16 weeks.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842567


Locations
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Italy
Hepatometabolic Department, Bambino Gesù Children's Hospital
Rome, Italy, 00165
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute

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Responsible Party: Valerio Nobili, Professor, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02842567     History of Changes
Other Study ID Numbers: 1066_OPBG_2016
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
3,4-dihydroxyphenylethanol
Phenylethyl Alcohol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Infective Agents
Platelet Aggregation Inhibitors
Anti-Infective Agents, Local
Disinfectants