NCT02112734Active, not recruitingPhase 4
Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2
Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2739 (actual)
- First submitted
- 10 Apr 2014
- Start date
- 1 Dec 2014
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Murdoch Childrens Research Institute
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT02112734
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 2739
- From 1 Dec 2014 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infants who are currently receiving vitamin D supplementation
- Infants on medication that interferes with vitamin D metabolism
Other illness
- Poor health due to a current or past significant disease state or congenital abnormality.
Age
- Prematurity \<37 weeks/low birth weight \<2500 g/Small for gestational age (SGA)
Other
- Participants meeting any of the following criteria will be excluded from the study:
- Unable to provide consent without the aid of an interpreter.
- Women at high risk of vitamin D deficiency with infants on vitamin D supplementation.
Who the study is looking for
- 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.
Age in the registry: 6 weeks to 12 weeks · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Murdoch Childrens Research Institute Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.