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

This study has been completed.
Sponsor:
Information provided by:
Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT00885313
First received: April 20, 2009
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Fatty Liver
Liver Fibrosis
Obesity
Metabolic Syndrome
Nonalcoholic Fatty Liver Disease
Drug: DHA250
Drug: DHA500
Drug: PLACEBO
Behavioral: Lifestyle intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Liver status by liver biopsy (steatosis and fibrosis) [ Time Frame: months 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum alanine transferase levels [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Serum levels of triglycerides [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: March 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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].
Drug: DHA500
DHA 500 mg/kg/d
Other Name: 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 Name: Diet and physical activity
Placebo Comparator: PLA
placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
Drug: PLACEBO
placebo
Other Name: No interventions
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 Name: Diet and physical activity

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.

  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: NCT00885313

Locations
Italy
Bambino Gesù Hospital and Research Institute
Rome, Italy, 00165
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Valerio Nobili, MD Bambino Gesù Children Hospital
  More Information

No publications provided by Bambino Gesù Hospital and Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valerio Nobili, MD, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT00885313     History of Changes
Other Study ID Numbers: 1406-18-4
Study First Received: April 20, 2009
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board
Italy: Ethics Committee

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 23, 2014