Trials / Completed
CompletedNCT00885313
Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)
Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- 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) 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 250 mg/kg/d (n=20), DHA 500 mg/kg/d (n=20), or an identical placebo (n=20) given orally for a period of 24 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 24-month study period. Liver biopsy will be performed only at baseline and at the end of treatment. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 24-month study duration. Ultrasonography and Fibroscan of the liver will be repeated at the end of the study period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DHA250 | DHA 250 mg/kg/d |
| DRUG | DHA500 | DHA 500 mg/kg/d |
| DRUG | PLACEBO | placebo |
| BEHAVIORAL | Lifestyle intervention | lifestyle intervention \[including hypocaloric diet (25-30 cal/kg/d) or isocaloric diet (40-45 cal/kg/d) and physical activity\], for 12 months. |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-04-01
- Completion
- 2011-03-01
- First posted
- 2009-04-21
- Last updated
- 2011-05-13
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00885313. Inclusion in this directory is not an endorsement.