title: VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health.
abstract: BACKGROUND
  Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6-8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY.
  Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited.
  
  
  BACKGROUND
  The VITALITY study is approved by the Royal Children's Hospital (RCH) Human Research Ethics Committee (#34168). Outcomes will be disseminated through publication and will be presented at scientific conferences.
  
  
  BACKGROUND
  ANZCTR12614000334606 and NCT02112734; pre-results.
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia The Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Katrina J
authors.initials: KJ
authors.lastname: Allen
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
authors.forename: Mary
authors.initials: M
authors.lastname: Panjari
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Koplin
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Anne-Louise
authors.initials: AL
authors.lastname: Ponsonby
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Vuillermin
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Centre for Epidemiology and Biostatistics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Lyle C
authors.initials: LC
authors.lastname: Gurrin
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia School of Medical Sciences, RMIT University, Bundoora, Victoria, Australia.
authors.forename: Ronda
authors.initials: R
authors.lastname: Greaves
authors.affiliation: Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Melbourne, Australia.
authors.forename: Natalie
authors.initials: N
authors.lastname: Carvalho
authors.affiliation: Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Melbourne, Australia.
authors.forename: Kim
authors.initials: K
authors.lastname: Dalziel
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Mimi L K
authors.initials: ML
authors.lastname: Tang
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia The Melbourne Children's Trials Centre (MCRI), Melbourne, Victoria, Australia.
authors.forename: Katherine J
authors.initials: KJ
authors.lastname: Lee
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Melissa
authors.initials: M
authors.lastname: Wake
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Nigel
authors.initials: N
authors.lastname: Curtis
authors.affiliation: The Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Shyamali C
authors.initials: SC
authors.lastname: Dharmage
mesh_terms: D001942:Breast Feeding; D002985:Clinical Protocols; D019587:Dietary Supplements; D004311:Double-Blind Method; D004485:Eczema / Q000188:drug therapy*; D005512:Food Hypersensitivity / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D012107:Research Design; D012141:Respiratory Tract Infections / Q000517:prevention & control*; D014807:Vitamin D / Q000627:therapeutic use*; D014808:Vitamin D Deficiency / Q000188:drug therapy*; D014815:Vitamins / Q000627:therapeutic use
chemical_list: D014815:Vitamins; D014807:Vitamin D
keywords: EPIDEMIOLOGY; PAEDIATRICS; PREVENTIVE MEDICINE