Status:
COMPLETED
Effect of Vitamin E on Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Bambino Gesù Hospital and Research Institute
Conditions:
Inflammation
Fibrosis
Eligibility:
All Genders
3-20 years
Phase:
PHASE2
PHASE3
Brief Summary
No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and adolescents. We aim to determine the efficacy of lifestyle intervention with or without antioxidant therapy in p...
Detailed Description
InChildren or adolescents with well-characterized and liver biopsy confirmed NAFLD will be enrolled. They will be randomized to treatment with alpha tocopherol 600 IU/d plus ascorbic acid 500 mg/d (n=...
Eligibility Criteria
Inclusion
- persistently elevated serum aminotransferase levels,
- diffusely echogenic liver on imaging studies suggestive of fatty liver, and
- 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,
- and use of drugs known to induce steatosis (e.g. valproate, amiodarone or prednisone) 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 :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00655018
Start Date
January 1 2003
End Date
October 1 2006
Last Update
April 9 2008
Active Locations (1)
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1
Dept. Of HepatoGastoEnterology and Nutrition, Liver Unit
Rome, Italy, 00165