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Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial
We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-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). 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 and other allergic disease at 12 months (part 1) and 6 years of age (part 2). 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.
Details
| Lead sponsor | Murdoch Childrens Research Institute |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 2739 |
| Start date | 2014-12 |
| Completion | 2028-12 |
Conditions
- Food Allergy
Interventions
- Vitamin D
- placebo
Primary outcomes
- The prevalence of challenge-proven food allergy at 12 months of age — At 12 months of age
The prevalence of challenge-proven food allergy at 12 months of age determined by a positive SPT and a positive oral food challenge - The occurrence of definite food allergy or tolerance at 6 years of age — At 6 years of age
The occurrence of definite food allergy or tolerance at 6 years of age can only be determined by combining data from an oral food challenge, a skin prick test (SPT) and/or serum specific IgE test, and/or parent/self-reported ingestion history and reactions to the index food.
Countries
Australia