Lifestyle intervention and antioxidant therapy in children with nonalcoholic fatty liver disease: a randomized, controlled trial.
No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and adolescents. We sought to determine the efficacy of lifestyle intervention with or without antioxidant therapy in pediatric NAFLD. A total of 53 patients (age 5.7-18.8 years, 37 boys) were included. Lifestyle intervention consisting of a diet tailored to the patient's calorie needs, and increased physical activity was prescribed in all. Patients were concomitantly randomized to alpha-tocopherol 600 IU/day plus ascorbic acid 500 mg/day (n = 25) or placebo (n = 28), and treated for 24 months. The study was an extension of a previous study aimed at evaluating the effect of 12-month lifestyle intervention and antioxidant therapy on serum levels of aminotransferases. The primary end point of the present study was change in liver histology on repeated biopsy at 24 months. Secondary end points were changes in body weight, liver enzymes, and insulin sensitivity indices on 2-hour oral glucose tolerance test. The amount of weight lost at 24 months was similar in the placebo and antioxidant groups (-4.75 [range, -16-4.0] versus -5.5 [range, -12.2-0.4] kg, respectively, P = 0.9). A significant improvement occurred in the grade of steatosis, lobular inflammation, and hepatocyte ballooning, and in the NAFLD activity score in both groups. Levels of aminotransferases, triglycerides, cholesterol, fasting glucose, and insulin, and insulin sensitivity indices improved significantly as well. The improvement in all these parameters was not significantly different between the two groups.


CONCLUSIONS
Lifestyle intervention with diet and increased physical activity induces weight loss and is associated with a significant improvement in liver histology and laboratory abnormalities in pediatric NAFLD. Alpha-tocopherol plus ascorbic acid does not seem to increase the efficacy of lifestyle intervention alone.
Nobili
Valerio
V
Liver Unit, "Bambino Gesù" Children's Hospital and Research Institute, Rome, Italy.
Manco
Melania
M
Devito
Rita
R
Di Ciommo
Vincenzo
V
Comparcola
Donatella
D
Sartorelli
Maria Rita
MR
Piemonte
Fiorella
F
Marcellini
Matilde
M
Angulo
Paul
P
D000293:Adolescent; D000975:Antioxidants / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000627:therapeutic use; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight; D002648:Child; D004038:Diet, Reducing; D004311:Double-Blind Method; D005081:Exercise Therapy; D005215:Fasting / Q000097:blood; D005234:Fatty Liver / Q000097:blood / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008019:Life Style; D008055:Lipids / Q000097:blood; D008099:Liver / Q000473:pathology; D008297:Male; D013997:Time Factors; D000637:Transaminases / Q000097:blood; D016896:Treatment Outcome; D024502:alpha-Tocopherol / Q000627:therapeutic use
D000975:Antioxidants; D001786:Blood Glucose; D007328:Insulin; D008055:Lipids; D000637:Transaminases; D024502:alpha-Tocopherol; D001205:Ascorbic Acid