Trials / Completed
CompletedNCT01934777
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
Study of Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Bambino Gesù Hospital and Research Institute · Academic / Other
- Sex
- All
- Age
- 4 Years – 16 Years
- Healthy volunteers
- Not accepted
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).
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, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docosahexaenoic Acid plus Vitamin E plus choline | DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg |
| DRUG | placebo pearls | placebo |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-10-01
- Completion
- 2015-07-01
- First posted
- 2013-09-04
- Last updated
- 2016-01-14
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01934777. Inclusion in this directory is not an endorsement.