Overview

Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bambino Gesù Hospital and Research Institute
Treatments:
alpha-Tocopherol
Choline
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Criteria
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