Fatty Liver, Liver Fibrosis, Metabolic Syndrome, Nonalcoholic Fatty Liver Disease, Obesity
Conditions
Keywords
NAFLD, NASH, fibrosis
Brief 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.
Interventions
DRUGDocosahexaenoic Acid plus Vitamin E plus choline
DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg
DRUGplacebo pearls
placebo
Sponsors
Bambino Gesù Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in NAFLD Activity Score (NAS) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography | 6 and 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 and 12 months | clinical examination, medical history and specific laboratory parameters |
Countries
Italy
Outcome results
None listed