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VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health

Allen, Katrina J., Panjari, Mary, Koplin, Jennifer J., Posonby, Anne-Louise, Vuillermin, Peter, Gurrin, Lyle C., Greaves, Ronda, Carvalho, Natalie, Dalziel, Kim, Tang, Mimi L.K., Lee, Katherine J., Wake, Melissa, Curtis, Nigel and Dharmage, Shyamali c. 2015, VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health, BMJ open, vol. 5, no. 12, pp. 1-8, doi: 10.1136/bmjopen-2015-009377.

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Title VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health
Author(s) Allen, Katrina J.
Panjari, Mary
Koplin, Jennifer J.
Posonby, Anne-Louise
Vuillermin, Peter
Gurrin, Lyle C.
Greaves, Ronda
Carvalho, Natalie
Dalziel, Kim
Tang, Mimi L.K.
Lee, Katherine J.
Wake, Melissa
Curtis, Nigel
Dharmage, Shyamali c.
Journal name BMJ open
Volume number 5
Issue number 12
Start page 1
End page 8
Total pages 8
Publisher BMJ Publishing Group
Place of publication London, Eng.
Publication date 2015
ISSN 2044-6055
Summary 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.
Language eng
DOI 10.1136/bmjopen-2015-009377
Field of Research 111401 Foetal Development and Medicine
Socio Economic Objective 920501 Child Health
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30084230

Document type: Journal Article
Collections: School of Medicine
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.