Omega-3 Fatty acids therapy in children with nonalcoholic Fatty liver disease: a randomized controlled trial
Janczyk W, Lebensztejn D, Wierzbicka-Rucińska A, Mazur A, Neuhoff-Murawska J, Matusik P, Socha P
The Journal of pediatrics · 101 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2015-03-11 · J Pediatr · vol. 166 · número 6 · págs. 1358–1363.e3
- Editorial
- Elsevier BV
- Citado
- 127 citas · más que el 99% de estudios similares · 11.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 23 trabajos
- Acceso
- De pago
- Áreas de investigación
- Liver Disease Diagnosis and Treatment · Fatty Acid Research and Health · Diet, Metabolism, and Disease
- Palabras clave
- omega-3 fatty acids, non-alcoholic fatty liver disease, childhood obesity, docosahexaenoic acid, eicosapentaenoic acid, aspartate aminotransferase, gamma-glutamyl transferase, adiponectin, insulin resistance, hepatic steatosis, dietary supplementation, alanine aminotransferase
- MeSH
- humans, gamma-glutamyltransferase, alanine transaminase, aspartate aminotransferases, fatty acids, omega-3, double-blind method, dietary supplements, adolescent, child, female, male, non-alcoholic fatty liver disease
7 autores
- Wojciech Jańczyk🇵🇱Children's Memorial Health Institute
- Dariusz Marek Lebensztejn🇵🇱Medical University of Białystok
- Aldona Wierzbicka🇵🇱Children's Memorial Health Institute
- Artur Mazur🇵🇱University of Rzeszów
- Joanna Neuhoff-Murawska🇵🇱Children's Memorial Health Institute
- Paweł Matusik🇵🇱Medical University of Silesia
- Piotr Socha🇵🇱 · autor de correspondenciaChildren's Memorial Health Institute
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To evaluate the efficacy and safety of omega-3 fatty acid supplementation in children with nonalcoholic fatty liver disease (NAFLD).
Study design
Overweight/obese children with NAFLD (n = 76; median age, 13 years; IQR, 11.1-15.2 years) were eligible to participate in the study. The diagnosis of NAFLD was based on elevated alanine aminotransferase (ALT) to ≥ 30% of the upper limit of normal (ULN) and liver hyperechogenicity on ultrasound. Patients were randomized to receive omega-3 fatty acids (docosahexaenoic acid and eicosapentaenoic acid, 450-1300 mg/day) or placebo (omega-6 sunflower oil). The primary outcome was the number of patients who demonstrated decreased ALT activity by ≥ 0.3 times the ULN. Secondary outcomes included alterations in liver function tests, liver hyperechogenicity, insulin resistance, and other metabolic markers after 6 months of intervention.
Results
Out of 76 enrolled patients, 64 completed the trial and were analyzed. After 6 months, we found no significant differences between the omega-3 and placebo groups in the number of patients with decreased ALT by ≥ 0.3 times the ULN (24 vs 23) or in median (IQR) ALT activity (48.5 [31-62] U/L vs 39 [27-55] U/L), liver hyperechogenicity, insulin resistance, or serum lipid levels. However, patients in the omega-3 group had lower levels of aspartate aminotransferase (28 [25-36] U/L vs 39 [27-55] U/L; P = .04) and gamma-glutamyl transpeptidase (26 [17.5-36.5] U/L vs 35 [22-52] U/L; P = .04), and significantly higher levels of adiponectin.
Conclusion
Omega-3 fatty acid supplementation did not increase the number of patients with decreased ALT levels and it did not affect liver steatosis on ultrasound, but it improved aspartate aminotransferase and gamma-glutamyl transpeptidase levels in children with NAFLD compared with placebo.
Trial registration
Registered with ClinicalTrials.gov: NCT01547910.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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