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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

April 20, 2009
May 12, 2011
March 2009
April 2010   (final data collection date for primary outcome measure)
Liver status by liver biopsy (steatosis and fibrosis) [ Time Frame: months 24 ] [ Designated as safety issue: Yes ]
Serum levels of aminotransferases [ Time Frame: months 12 and 24 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00885313 on ClinicalTrials.gov Archive Site
  • 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 ]
Liver status (steatosis and fibrosis) [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)
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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Fatty Liver
  • Liver Fibrosis
  • Obesity
  • Metabolic Syndrome
  • Nonalcoholic Fatty Liver Disease
  • Drug: DHA250
    DHA 250 mg/kg/d
    Other Name: Docosahexaenoic Acid
  • Drug: DHA500
    DHA 500 mg/kg/d
    Other Name: Docosahexaenoic Acid
  • 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
  • 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].
    Interventions:
    • Drug: DHA250
    • Behavioral: Lifestyle intervention
  • 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].
    Interventions:
    • Drug: DHA500
    • Behavioral: Lifestyle intervention
  • Placebo Comparator: PLA
    placebo and lifestyle intervention [hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity].
    Interventions:
    • Drug: PLACEBO
    • Behavioral: Lifestyle intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2011
April 2010   (final data collection date for primary outcome measure)

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
Both
4 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00885313
1406-18-4
Yes
Valerio Nobili, MD, Bambino Gesù Hospital and Research Institute
Bambino Gesù Hospital and Research Institute
Not Provided
Principal Investigator: Valerio Nobili, MD Bambino Gesù Children Hospital
Bambino Gesù Hospital and Research Institute
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP