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

Phase 3

Completed

• Conditions: Metabolic Syndrome; Liver Fibrosis; Fatty Liver; Obesity; Nonalcoholic Fatty Liver Disease
• Interventions: Drug: Docosahexaenoic Acid plus Vitamin E plus choline; Drug: placebo pearls

• Registration Number: NCT01934777
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

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.

Study Timeline

• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-04
• Study Start: 2013-10
• Primary Completion: 2014-10
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TREATED GROUP	Docosahexaenoic Acid plus Vitamin E plus choline	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
PLACEBO GROUP	placebo pearls	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

Primary Outcome Measures

Name	Time	Method
Improvement in NAFLD Activity Score (NAS)	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bambino Gesù Hospital and Research Institute; 🇮🇹 Rome, Rome, Italy, Italy