EFFICACY AND TOLERANCE OF TREATMENT WITH DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

This study is not yet open for participant recruitment.
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: NA
Last verified: August 2013
History: No changes posted
  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, Vitamin E, choline
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:
  • Liver status (steatosis and fibrosis) by ultrasonographic and fibroscan [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum alanine transferase levels [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Serum levels of triglycerides [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA,VITAMIN E, CHOLINE
DHA, VITAMIN E AND CHOLINE BY MOUTH EVERY DAY FOR 12 MONTHS
Drug: Docosahexaenoic Acid, Vitamin E, choline
DHA, Vitamin E and Choline plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Other Name: Docosahexaenoic Acid, Alpha tocopherol, choline
Drug: placebo
placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Other Name: placebo
Active Comparator: placebo
placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Drug: Docosahexaenoic Acid, Vitamin E, choline
DHA, Vitamin E and Choline plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Other Name: Docosahexaenoic Acid, Alpha tocopherol, choline
Drug: placebo
placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
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 only at baseline Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonographyof 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
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 Not yet 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: August 30, 2013
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
Fatty Liver
Fibrosis
Liver Diseases
Obesity
Liver Cirrhosis
Metabolic Syndrome X
Digestive System Diseases
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Choline
Vitamins
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014