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

Phase 1

Completed

• Conditions: Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease
• Interventions: Drug: DHA250; Drug: DHA500; Drug: PLACEBO; Behavioral: Lifestyle intervention

• Registration Number: NCT00885313
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief 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).

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2010-04
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA250	DHA250	DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
DHA250	Lifestyle intervention	DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
DHA500	DHA500	DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
DHA500	Lifestyle intervention	DHA 250 mg/kg/d plus lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
PLA	PLACEBO	placebo and lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].
PLA	Lifestyle intervention	placebo and lifestyle intervention \[hypocaloric Diet (25-30 cal/kg/d) or isocaloric (40-45 cal/kg/d) and physical activity\].

Primary Outcome Measures

Name	Time	Method
Liver status by liver biopsy (steatosis and fibrosis)	months 24

Secondary Outcome Measures

Name	Time	Method
Serum alanine transferase levels	month 24
Serum levels of triglycerides	24 months

Trial Locations

Locations (1)

Bambino Gesù Hospital and Research Institute; 🇮🇹 Rome, Italy