Article Text

Download PDFPDF

VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health
  1. Katrina J Allen1,2,3,
  2. Mary Panjari1,
  3. Jennifer J Koplin1,2,
  4. Anne-Louise Ponsonby1,2,
  5. Peter Vuillermin1,
  6. Lyle C Gurrin1,4,
  7. Ronda Greaves1,5,
  8. Natalie Carvalho6,
  9. Kim Dalziel6,
  10. Mimi L K Tang1,2,
  11. Katherine J Lee1,2,7,
  12. Melissa Wake1,2,
  13. Nigel Curtis1,2,
  14. Shyamali C Dharmage1,3
  1. 1The Murdoch Childrens Research Institute, Parkville, Victoria, Australia
  2. 2The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia
  3. 3The Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Victoria, Australia
  4. 4The Centre for Epidemiology and Biostatistics, University of Melbourne, Parkville, Victoria, Australia
  5. 5School of Medical Sciences, RMIT University, Bundoora, Victoria, Australia
  6. 6Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Melbourne, Australia
  7. 7The Melbourne Children's Trials Centre (MCRI), Melbourne, Victoria, Australia
  1. Correspondence to Professor Katrina J Allen; katirina.allen{at}


Introduction 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.

Methods nd analysis 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.

Ethics and dissemination 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.

Trial registration numbers ANZCTR12614000334606 and NCT02112734; pre-results.


This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See:

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.