Title |
VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health
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Published in |
BMJ Open, December 2015
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DOI | 10.1136/bmjopen-2015-009377 |
Pubmed ID | |
Authors |
Katrina J Allen, Mary Panjari, Jennifer J Koplin, Anne-Louise Ponsonby, Peter Vuillermin, Lyle C Gurrin, Ronda Greaves, Natalie Carvalho, Kim Dalziel, Mimi L K Tang, Katherine J Lee, Melissa Wake, Nigel Curtis, Shyamali C Dharmage |
Abstract |
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. 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. ANZCTR12614000334606 and NCT02112734; pre-results. |
X Demographics
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Unknown | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Australia | 1 | <1% |
Unknown | 149 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Bachelor | 25 | 17% |
Student > Master | 21 | 14% |
Student > Ph. D. Student | 12 | 8% |
Researcher | 11 | 7% |
Other | 9 | 6% |
Other | 32 | 21% |
Unknown | 40 | 27% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 47 | 31% |
Nursing and Health Professions | 20 | 13% |
Biochemistry, Genetics and Molecular Biology | 11 | 7% |
Economics, Econometrics and Finance | 7 | 5% |
Agricultural and Biological Sciences | 5 | 3% |
Other | 15 | 10% |
Unknown | 45 | 30% |