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

Bambino Gesù Hospital and Research Institute

Status and phase: Completed; Phase 3

Conditions: Fatty Liver; Nonalcoholic Fatty Liver Disease; Obesity; Liver Fibrosis; Metabolic Syndrome

Treatments: Drug: placebo pearls; Drug: Docosahexaenoic Acid plus Vitamin E plus choline

Study type: Interventional

Funder types: Other

Identifiers

NCT01934777

OPBG-DHA, VIT E, CHOLINE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

TREATED GROUP

Experimental group

Description:

DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg by mouth every day in association with lifestyle intervention \[hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity\] for 6 months

Treatment:

Drug: Docosahexaenoic Acid plus Vitamin E plus choline

PLACEBO GROUP

Placebo Comparator group

Description:

placebo: this group will treated with identical placebo pearls given orally in association with lifestyle intervention \[hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity\] for 6 months

Treatment:

Drug: placebo pearls