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

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ClinicalTrials.gov Identifier: NCT01934777
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Valerio Nobili, Bambino Gesù Hospital and Research Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in NAFLD Activity Score (NAS) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Safety [ Time Frame: 6 and 12 months ]
    clinical examination, medical history and specific laboratory parameters


Eligibility Criteria
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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:

  • 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
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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): NCT01934777


Locations
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Italy
Bambino Gesù Hospital and Research Institute
Rome, Rome, Italy, Italy, 00165
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
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Principal Investigator: Valerio Nobili, MD Bambino Gesù Children Hospital
More Information
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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    
Other Study ID Numbers: OPBG-DHA, VIT E, CHOLINE
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
Keywords provided by Valerio Nobili, Bambino Gesù Hospital and Research Institute:
NAFLD
NASH
fibrosis
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Fibrosis
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Vitamin E
Choline
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents