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

Janczyk W, Socha P, Lebensztejn D, Wierzbicka A, Mazur A, Neuhoff-Murawska J, Matusik P - BMC Pediatr (2013)

Bottom Line: 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.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.NCT01547910.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department Gastroenterology, Hepatology and Eating Disorders, Children's Memorial Health Institute, Warsaw, Poland. w.janczyk@czd.pl

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.

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Related in: MedlinePlus

Patient CONSORT flowchart.
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Figure 2: Patient CONSORT flowchart.

Mentions: Children aged 6 to 19 years old were recruited at the 4 Polish pediatric hospitals from July 2008 till April 2011 (the participating centers are listed in the acknowledgments). In total 76 patients were enrolled into the trial according to the screening procedures. All participants and their parents gave written consent before enrollment. Ethical approval was obtained from the Children’s Memorial Health Institute Bioethical Committee, Warsaw, Poland. The CONSORT flowchart is presented on Figure 2.


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

Janczyk W, Socha P, Lebensztejn D, Wierzbicka A, Mazur A, Neuhoff-Murawska J, Matusik P - BMC Pediatr (2013)

Patient CONSORT flowchart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3672084&req=5

Figure 2: Patient CONSORT flowchart.
Mentions: Children aged 6 to 19 years old were recruited at the 4 Polish pediatric hospitals from July 2008 till April 2011 (the participating centers are listed in the acknowledgments). In total 76 patients were enrolled into the trial according to the screening procedures. All participants and their parents gave written consent before enrollment. Ethical approval was obtained from the Children’s Memorial Health Institute Bioethical Committee, Warsaw, Poland. The CONSORT flowchart is presented on Figure 2.

Bottom Line: 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.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.NCT01547910.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department Gastroenterology, Hepatology and Eating Disorders, Children's Memorial Health Institute, Warsaw, Poland. w.janczyk@czd.pl

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.

Show MeSH
Related in: MedlinePlus