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

Last updated: January 13, 2016
Sponsor: Bambino Gesù Hospital and Research Institute
Overall Status: Completed

Phase

3

Condition

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT01934777
OPBG-DHA, VIT E, CHOLINE
  • Ages 4-16
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 carbohydratemetabolism

  • autoimmune liver disease, metabolic liver disease, Wilson's disease, anda-1-antitrypsin-associated liver disease were ruled out using standard clinical,laboratory and histological criteria

Study Design

Total Participants: 60
Study Start date:
October 01, 2013
Estimated Completion Date:
July 31, 2015

Study Description

Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA, VIT E and Choline (n=30)or an identical placebo (n=30) given orally for a period of 12 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 12-month study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonography of the liver will be repeated after six months at the end of the study period.

Connect with a study center

  • Bambino Gesù Hospital and Research Institute

    Rome, Rome, Italy 00165
    Italy

    Site Not Available

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