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

摘要: 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 the Northern hemisphere recommend universal infant to optimise early levels, despite absence of large trials proving safety or efficacy for any disease outcome. With aim determining clinical cost-effectiveness daily breastfed infants from age 6–8 weeks 12 months age, we have started double-blind, randomised, placebo-controlled trial 400 IU during first year life, VITALITY. Methods nd analysis Infants (n=3012) who are fully not receiving will recruited at time their immunisation, council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven allergy age. Secondary outcomes sensitisation (positive skin prick test), number (through hospital linkage), moderately-severe persistent eczema (by history examination) deficiency (serum Ethics dissemination VITALITY study approved by Royal Children9s Hospital (RCH) Human Research Committee (#34168). Outcomes disseminated through publication presented scientific conferences. Trial registration numbers ANZCTR12614000334606 NCT02112734; pre-results.