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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Bambino Gesù Hospital and Research Institute
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT01934777
First received: August 30, 2013
Last updated: June 24, 2014
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Fatty Liver
Liver Fibrosis
Obesity
Metabolic Syndrome
Nonalcoholic Fatty Liver Disease
Drug: Docosahexaenoic Acid plus Vitamin E plus choline
Drug: placebo pearls
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Resource links provided by NLM:


Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • Improvement in NAFLD Activity Score (NAS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Safety [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
    clinical examination, medical history and specific laboratory parameters


Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Docosahexaenoic Acid plus Vitamin E plus choline
DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg
Other Name: Docosahexaenoic Acid plus Vitamin E plus choline
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
Drug: placebo pearls
placebo
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934777

Contacts
Contact: Valerio Nobili, MD nobili66@yahoo.it

Locations
Italy
Bambino Gesù Hospital and Research Institute Recruiting
Rome, Rome, Italy, Italy, 00165
Contact: Valerio Nobili, MD    06/68592192    nobili66@yahoo.it   
Principal Investigator: Valerio Nobili, MD         
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Valerio Nobili, MD Bambino Gesù Children Hospital
  More Information

No publications provided

Responsible Party: Valerio Nobili, Head of Hepato-Metabolic Disease Unit, Bambino Gesù Children Hospital, IRCCS, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT01934777     History of Changes
Other Study ID Numbers: OPBG-DHA, VIT E, CHOLINE
Study First Received: August 30, 2013
Last Updated: June 24, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Bambino Gesù Hospital and Research Institute:
NAFLD
NASH
fibrosis

Additional relevant MeSH terms:
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Fibrosis
Metabolic Syndrome X
Liver Diseases
Fatty Liver
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Vitamins
Choline
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents

ClinicalTrials.gov processed this record on September 30, 2014