Wojciech Janczyk1, Dariusz Lebensztejn2, Aldona Wierzbicka-Rucińska3, Artur Mazur4, Joanna Neuhoff-Murawska1, Paweł Matusik5, Piotr Socha6. 1. Department of Gastroenterology, Hepatology and Nutrition Disorders, The Children's Memorial Health Institute, Warsaw, Poland. 2. Department of Pediatrics, Gastroenterology, and Allergology, Medical University of Bialystok, Bialystok, Poland. 3. Department of Biochemistry and Radioimmunology, The Children's Memorial Health Institute, Warsaw, Poland. 4. Medical Faculty, University of Rzeszow, Rzeszow, Poland. 5. Department of Pediatrics, Pediatric Endocrinology and Diabetes, Medical University of Silesia, Katowice, Poland. 6. Department of Gastroenterology, Hepatology and Nutrition Disorders, The Children's Memorial Health Institute, Warsaw, Poland. Electronic address: p.socha@czd.pl.
Abstract
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.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of omega-3 fatty acid supplementation in children with nonalcoholic fatty liver disease (NAFLD). STUDY DESIGN: Overweight/obesechildren 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.
Authors: Roshonda B Jones; Lide Arenaza; Claudia Rios; Jasmine F Plows; Paige K Berger; Tanya L Alderete; Jennifer L Fogel; Krishna Nayak; Passant Mohamed; Darryl Hwang; Suzanne Palmer; Frank Sinatra; Hooman Allayee; Rohit Kohli; Michael I Goran Journal: Nutrients Date: 2021-05-12 Impact factor: 5.717