Inflammation Clinical Trial
— VITENAFLDOfficial title:
Lifestyle Intervention and Antioxidants in Children With Nonalcoholic Fatty Liver Disease: A Randomized, Controlled Trial
Verified date | March 2008 |
Source | Bambino Gesù Hospital and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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 pediatric NAFLD.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 20 Years |
Eligibility |
Inclusion Criteria: - persistently elevated serum aminotransferase levels, - diffusely echogenic liver on imaging studies suggestive of fatty liver, and - 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, - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Dept. Of HepatoGastoEnterology and Nutrition, Liver Unit | Rome |
Lead Sponsor | Collaborator |
---|---|
Bambino Gesù Hospital and Research Institute |
Italy,
Bugianesi E, Gentilcore E, Manini R, Natale S, Vanni E, Villanova N, David E, Rizzetto M, Marchesini G. A randomized controlled trial of metformin versus vitamin E or prescriptive diet in nonalcoholic fatty liver disease. Am J Gastroenterol. 2005 May;100(5):1082-90. — View Citation
Lavine JE. Vitamin E treatment of nonalcoholic steatohepatitis in children: a pilot study. J Pediatr. 2000 Jun;136(6):734-8. — View Citation
Nobili V, Manco M, Devito R, Ciampalini P, Piemonte F, Marcellini M. Effect of vitamin E on aminotransferase levels and insulin resistance in children with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1553-61. — View Citation
Vajro P, Mandato C, Franzese A, Ciccimarra E, Lucariello S, Savoia M, Capuano G, Migliaro F. Vitamin E treatment in pediatric obesity-related liver disease: a randomized study. J Pediatr Gastroenterol Nutr. 2004 Jan;38(1):48-55. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum levels of aminotransferases | months 12 and 24 | Yes | |
Secondary | Liver histology (inflammation and fibrosis) | month 24 | No |
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