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ACTIVE NOT RECRUITING
NCT02112734
PHASE4

Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2

Sponsor: Murdoch Childrens Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial

Key Details

Gender

All

Age Range

6 Weeks - 12 Weeks

Study Type

INTERVENTIONAL

Enrollment

2739

Start Date

2014-12

Completion Date

2028-12

Last Updated

2025-12-03

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Vitamin D

400 IU/daily until age 12 months

DRUG

placebo

identical placebo daily

Locations (1)

Murdoch Childrens Research Institute

Melbourne, Victoria, Australia