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

Overview

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).

Full Title of Study: “Study of Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2014

Detailed Description

Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA, VIT E and Choline (n=30)or an identical placebo (n=30) given orally for a period of 12 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.

Patients will undergo a medical evaluation every three months during the 12-month study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonography of the liver will be repeated after six months at the end of the study period.

Interventions

  • Drug: Docosahexaenoic Acid plus Vitamin E plus choline
    • DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg
  • Drug: placebo pearls
    • placebo

Arms, Groups and Cohorts

  • Experimental: TREATED GROUP
    • DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg by mouth every day in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 6 months
  • Placebo Comparator: PLACEBO GROUP
    • placebo: this group will treated with identical placebo pearls given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in NAFLD Activity Score (NAS)
    • Time Frame: 12 months

Secondary Measures

  • Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography
    • Time Frame: 6 and 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • persistently elevated serum aminotransferase levels
  • diffusely echogenic liver on imaging studies suggestive of fatty liver
  • biopsy consistent with the diagnosis of NAFLD

Exclusion Criteria

  • hepatic virus infections (HCV RNA-PCR negative)
  • Hepatitis A, B, C, D, E and G
  • cytomegalovirus and Epstein-Barr virus
  • alcohol consumption
  • history of parenteral nutrition
  • use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
  • autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bambino Gesù Hospital and Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Valerio Nobili, Head of Hepato-Metabolic Disease Unit, Bambino Gesù Children Hospital, IRCCS – Bambino Gesù Hospital and Research Institute
  • Overall Official(s)
    • Valerio Nobili, MD, Principal Investigator, Bambino Gesù Children Hospital

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