Author information
1
Hepatology Gastroenterology and Nutrition, Bambino Gesù Children's Hospital, Rome, Italy. , Piazza Sant'Onofrio,4 , Rome, Italy , 00165 ; nobili66@yahoo.it.
2
Research Unit of Molecular Genetics of Complex Phenotypes, Bambino Gesù Children's Hospital , V.le San Paolo 15 , Rome, Italy , 00146 ; anna.alisi@opbg.net.
3
Hepatology Gastroenterology and Nutrition, Bambino Gesù Children's Hospital, Rome, Italy. , Piazza Sant'Onofrio,4 , Rome, Italy , 00165 ; antonella.mosca@opbg.net.
4
Bambino Gesù Children's Hospital, Rome, Italy, rome, Italy ; annalisa.crudele@opbg.net.
5
Ospedale Bambino Gesu, Occupational Medicine Unit, rome, Italy ; salvatore.zaffina@opbg.net.
6
University of Messina, Messina, Italy ; denaromarcella.md@gmail.com.
7
University of Messina, Italy, Messina, Italy ; asmeriglio@unime.it.
8
University of Messina, Messina, Italy ; dtrombetta@unime.it.
Abstract
TRIAL DESIGN:
Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in children. Several studies suggest that the improvement of oxidative stress is suggested as a possible therapeutic strategy for paediatric NASH. We performed a randomized double-blind placebo-controlled trial to test the potential efficacy, assessed by improvement of oxidative-stress parameters and liver ultrasound, and tolerability of a mixture of vitamin E and Hydroxytyrosol (HXT) in adolescents with biopsy-proven NAFLD.
METHODS:
440 consecutive patients were screened, 80 of these with biopsy-proven NAFLD were enrolled. Forty patients received an oral dose of HXT and vitamin E and 40 children received the capsules of placebo, for 4 months.
RESULTS:
Seventy patients completed the study. Patients in the treatment arm showed a decrease of insulin-resistance, triglyceride levels, oxidative-stress parameters and steatosis grade. Noteworthy, the steatosis improvement correlates with the levels of advanced glycation end products and carbonylated proteins.
CONCLUSION:
The HXT and vitamin E treatment improved the main oxidative-stress parameters, insulin resistance and steatosis in children with NAFLD. The use of two natural molecules that may have antioxidant effects seems a promising strategy that could be easily diet integrated to improve NAFLD related liver damage in children.