Vitamin d for babies: a simple way to stop food allergies?
NCT ID NCT02112734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving vitamin D supplements to healthy, breastfed infants during their first year can lower their risk of developing food allergies. Over 2,700 babies in Australia are involved, where food allergy rates are very high. Researchers will check for allergies at 12 months and again at 6 years old.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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2,739 people
The number who actually took part.
- Started
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Dec 2014
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 12 weeks
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Murdoch Childrens Research Institute
Melbourne, Victoria, 3052, Australia
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Other studies related to the condition(s) this trial covers.
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