Status:
COMPLETED
Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Bambino Gesù Hospital and Research Institute
Conditions:
Fatty Liver
Liver Fibrosis
Eligibility:
All Genders
4-16 years
Phase:
PHASE1
PHASE2
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 nonalc...
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 pl...
Eligibility Criteria
Inclusion
- persistently elevated serum aminotransferase levels
- diffusely echogenic liver on imaging studies suggestive of fatty liver
- biopsy consistent with the diagnosis of NAFLD
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00885313
Start Date
March 1 2009
End Date
March 1 2011
Last Update
May 13 2011
Active Locations (1)
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1
Bambino Gesù Hospital and Research Institute
Rome, Rome, Italy, 00165