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

Obesity Clinical Trial

— EDACN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885313
• Other study ID #: 1406-18-4
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 20, 2009
• Last updated: May 12, 2011
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardItaly: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Liver Fibrosis
• Metabolic Syndrome
• Metabolic Syndrome X
• Nonalcoholic Fatty Liver Disease
• Obesity

Intervention

Drug:
• DHA250
DHA 250 mg/kg/d
• DHA500
DHA 500 mg/kg/d
• PLACEBO
placebo

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.

Locations

Country	Name	City	State
Italy	Bambino Gesù Hospital and Research Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver status by liver biopsy (steatosis and fibrosis)		months 24	Yes
Secondary	Serum alanine transferase levels		month 24	Yes
Secondary	Serum levels of triglycerides		24 months	Yes