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Clinical Trials in Australia / NCT02112734
Active, not recruiting Phase 4

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

NCT02112734 · tracked via the Priya Life Science Australia tracker
Sponsor
Murdoch Childrens Research Institute
Phase
Phase 4
Started
2014-12
Last updated
2025-12-03

Condition(s) studied

Food Allergy

Investigational drug(s) / intervention(s)

Vitamin D →placebo

Vitamin D: 400 IU/daily until age 12 months

placebo: identical placebo daily

Study 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.

Eligibility

Sex
ALL
Min age
6 Weeks
Max age
12 Weeks
Healthy volunteers
Accepted
Inclusion Criteria: Each participant must meet the following criteria to be included in this study: * Healthy, term (born no earlier than 2 weeks before estimated date of delivery), predominantly breastfeeding infants aged 6 to 12 weeks (inclusive) who are expected to be predominantly breastfed for at least 6-months. This will be determined by answering yes/no to question 'do you intend/wish to breastfeed until your infant is at least 6 months of age.' Up to one bottle (approx. 120mL) of formula per 24 hours at the time of screening is acceptable, as this will contain \<100 IU vitamin D. * Has a parent/legally acceptable representative (LAR) capable of understanding the informed consent document and providing consent on the subject's behalf, * The parent must expect to be able to complete 4 online questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing (+/- food challenge) at The Royal Children's Hospital at 12 months of age. Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study: * Infants who are currently receiving vitamin D supplementation * Infants on medication that interferes with vitamin D metabolism * Poor health due to a current or past significant disease state or congenital abnormality. * Prematurity \<37 weeks/low birth weight \<2500 g/Small for gestational age (SGA) * Unable to provide consent without the aid of an interpreter. * Women at high risk of vitamin D deficiency with infants on vitamin D supplementation.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Murdoch Childrens Research Institute Melbourne Victoria

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02112734 on ClinicalTrials.gov ↗ ← All trials in Australia