title: Vitamin E for the treatment of E-antigen-positive chronic hepatitis B in paediatric patients: results of a randomized phase 2 controlled study.
abstract: The treatment of chronic hepatitis B infection (CHB) in children is still an area of great uncertainty. Vitamin E is an immunostimulating/antioxidant compound proven to be safe and effective for the treatment of adult CHB. The aim of this phase 2 controlled study was to evaluate the safety and efficacy of vitamin E for the treatment of paediatric HBeAg-positive CHB.
  
  
  
  Forty-six children were randomized in a 1:1 ratio to receive vitamin E at a dose of 15 mg/kg/day (in galenic preparation) or no treatment for 12 months and were monitored for the subsequent 12 months. Clinical, biochemical, haematological and serovirological evaluations were carried out every 3 months.
  
  
  
  No significant side effects were associated with the vitamin E treatment. At the end of the study, anti-HBe seroconversion was obtained in 7 of 23 (30.4%) of vitamin E-treated versus 1 of 23 (4.3%) of the control patients (P = 0.05), while a virological response (≥2 log decrease in HBV-DNA from baseline) was observed in 9 of 23 (39.1%) vs. 2 of 23 (8.7%) respectively (P = 0.035).
  
  
  
  Vitamin E administration for the treatment of paediatric CHB at the tested dosage has no significant side effects and may induce anti-HBe seroconversion. Vitamin E could represent a tool for the treatment of paediatric CHB.
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.|Unità Operativa di Medicina Interna, Ospedale Maggiore, AUSL Bologna, Bologna, Italy.
authors.forename: Sirio
authors.initials: S
authors.lastname: Fiorino
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Loggi
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Verucchi
authors.affiliation: Unità Operativa Malattie Epatometaboliche, Ospedale Pediatrico del Bambin Gesù, Rome, Italy.
authors.forename: Donatella
authors.initials: D
authors.lastname: Comparcola
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Ranka
authors.initials: R
authors.lastname: Vukotic
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Pavoni
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Grandini
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Cursaro
authors.affiliation: Unità Operativa di Farmacia Clinica, Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Maselli
authors.affiliation: Unità Operativa Malattie Cardiovascolari, Università di Bologna, Bologna, Italy.
authors.forename: Maria L
authors.initials: ML
authors.lastname: Bacchi Reggiani
authors.affiliation: Unità Operativa di Farmacia Clinica, Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Puggioli
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Badia
authors.affiliation: Unità Operativa di Microbiologia e Virologia, Azienda Ospedaliero Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Galli
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Viale
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Bernardi
authors.affiliation: Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Andreone
mesh_terms: D000293:Adolescent; D000975:Antioxidants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D007558:Italy; D008297:Male; D011446:Prospective Studies; D000072230:Sustained Virologic Response; D014810:Vitamin E / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000975:Antioxidants; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006513:Hepatitis B e Antigens; D014810:Vitamin E
keywords: chronic hepatitis B; paediatric infection; treatment; vitamin E