Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD) (EDACN)

May 12, 2011 updated by: Bambino Gesù Hospital and Research Institute

Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 250 mg/kg/d (n=20), DHA 500 mg/kg/d (n=20), or an identical placebo (n=20) given orally for a period of 24 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 24-month study period. Liver biopsy will be performed only at baseline and at the end of treatment. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. Ultrasonography and Fibroscan of the liver will be repeated at the end of the study period.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Bambino Gesù Hospital and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DHA250
DHA 250 mg/kg/d plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Drug: DHA250
DHA 250 mg/kg/d
Other Names:
  • Docosahexaenoic Acid
Behavioral: Lifestyle intervention
lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months.
Other Names:
  • Diet and physical activity
Experimental: DHA500
DHA 250 mg/kg/d plus lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Behavioral: Lifestyle intervention
lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months.
Other Names:
  • Diet and physical activity
Drug: DHA500
DHA 500 mg/kg/d
Other Names:
  • Docosahexaenoic Acid
Placebo Comparator: PLA
placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Behavioral: Lifestyle intervention
lifestyle intervention [including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity], for 12 months.
Other Names:
  • Diet and physical activity
Drug: PLACEBO
placebo
Other Names:
  • No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Liver status by liver biopsy (steatosis and fibrosis)
Time Frame: months 24
months 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum alanine transferase levels
Time Frame: month 24
month 24
Serum levels of triglycerides
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambino Gesù Hospital and Research Institute

Investigators

  • Principal Investigator: Valerio Nobili, MD, Bambino Gesu Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1406-18-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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