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Open Access Study protocol

Omega-3 fatty acids for treatment of non-alcoholic fatty liver disease: design and rationale of randomized controlled trial

Wojciech Janczyk1*, Piotr Socha1, Dariusz Lebensztejn2, Aldona Wierzbicka3, Artur Mazur4, Joanna Neuhoff-Murawska1 and Pawel Matusik5

Author Affiliations

1 Department Gastroenterology, Hepatology and Eating Disorders, Children’s Memorial Health Institute, Warsaw, Poland

2 Department of Pediatrics, Gastroenterology and Allergology, Medical University of Bialystok, Bialystok, Poland

3 Laboratory Diagnostics, Children's Memorial Health Institute, Warsaw, Poland

4 Medical Faculty, University of Rzeszow, Rzeszow, Poland

5 Departament Pediatric Endocrinology and Diabetes, Medical University of Silesia, Katowice, Poland

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BMC Pediatrics 2013, 13:85  doi:10.1186/1471-2431-13-85

Published: 23 May 2013

Abstract

Background

Non-alcoholic fatty liver disease (NAFLD) is a liver manifestation of metabolic syndrome since obesity and insulin resistance are the main pathogenic contributors for both conditions. NAFLD carries increased risk of atherosclerosis and cardiovascular diseases. There is an urgent need to find effective and safe therapy for children and adults with NAFLD. Data from research and clinical studies suggest that omega-3 fatty acids may be beneficial in metabolic syndrome-related conditions and can reduce the risk of cardiovascular disease.

Methods/design

We are conducting a randomized, multicenter, double-blind, placebo-controlled trial of treatment with omega-3 fatty acids in children with NAFLD. Patients are randomized to receive either omega-3 fatty acids containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) or placebo for 24 weeks. The dose of omega-3 (DHA+ EPA) ranges from 450 to 1300 mg daily. Low calorie diet and increased physical activity are advised and monitored using validated questionnaires. The primary outcome of the trial is the number of patients who decreased ALT activity by ≥ 0,3 of upper limit of normal. The main secondary outcomes are improvement in the laboratory liver tests, liver steatosis on ultrasound, markers of insulin resistance and difference in fat/lean body mass composition after 6 months of intervention.

Discussion

Potential efficacy of omega-3 fatty acids in the treatment of NAFLD will provide needed rationale for use of this safe diet supplement together with weight reduction therapy in the growing population of children with NAFLD.

Trial registration

NCT01547910

Keywords:
Non-alcoholic fatty liver disease; Omega-3 fatty acids; Polyunsaturated fatty acids; Randomized controlled trial; Children