Can Vitamin D Supplementation in Infants Prevent Food Allergy in the First Year of Life? The VITALITY Trial
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
There is an urgent need to prevent the onset and progression of food allergy in our
population. Evidence demonstrates that food allergy and atopic eczema represent the earliest
manifestations of the atopic march with 50% of infants with food allergy predicted to develop
respiratory allergic diseases later in life. We report that Australia has the highest
prevalence of IgE-mediated food allergy in the world, with 10% of infants having
challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital
admissions for life-threatening anaphylaxis. These changes are most pronounced in children
less than 5 years, suggesting a causal role for early life determinants. We have primary data
to inform hypotheses for the rise in food allergy, which appears to result from potentially
modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency
(VDI), and have demonstrated an association between VDI and increased risk of
challenge-proven food allergy in 12-month old infants, which supports numerous ecological
studies showing an increased risk of food allergy the further a child resides from the
equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's
sunny climate, population rates of VDI have steadily increased in infants and pregnant women
in parallel to the apparent rise in food allergic disease. This association is biologically
plausible, as there is evidence Vitamin D is critical to the healthy development of the
immune system in early life. We propose an intervention study to assess if infant Vitamin D
supplementation during the first year of life significantly decreases the risk of early-onset
food allergy. Australia is ideally placed to answer this important question since, unlike the
USA, Canada and Europe, there are no population recommendations for routine infant
supplementation with Vitamin D and we are one of the few developed countries that do not
supplement the food chain supply with Vitamin D.
Phase:
Phase 4
Details
Lead Sponsor:
Murdoch Childrens Research Institute
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins