Food AllergyPhase 4VITALITYNCT02112734
Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2
A Phase 4 study testing Vitamin D in people with Food Allergy, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,739 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2014to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Murdoch Childrens Research Institute
Melbourne, Victoria, 3052
About this study
Official title: 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.
Read the detailed description
There is an urgent need to prevent the onset and progression of food allergy in our population. Evidence demonstrates that food allergy and atopic eczema represent the earliest manifestations of the atopic march with 50% of infants with food allergy predicted to develop respiratory allergic diseases later in life. 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), and have demonstrated an association between VDI and increased risk of challenge-proven food allergy in 12-month old infants, which supports numerous ecological studies showing an increased risk of food allergy the further a child resides from the equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's sunny climate, population rates of VDI have steadily increased in infants and pregnant women in parallel to the apparent rise in food allergic disease. This association is biologically plausible, as there is evidence Vitamin D is critical to the healthy development of the immune system in early life. 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.
- Conditions
- Food Allergy
- Being tested
- Vitamin D, placebo
- Keywords
- vitamin D, food allergy, eczema
- Medical subject headings
- Food Hypersensitivity, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called cholecalciferol
400 IU/daily until age 12 months
placeboDrug
Also called placebo is identical carrier minus vitamin D
identical placebo daily
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Active comparator | 400 IU /daily cholecalciferol/vitamin D Receives: Drug: Vitamin D |
| placebo | Placebo comparator | carrier formulation minus vitamin D Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of challenge-proven food allergy 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
Measured: At 12 months of age
The occurrence of definite food allergy or tolerance 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.
Measured: At 6 years of age
Secondary outcomes (23)
The prevalence of food sensitisation at 12 months of age determined by SPT positive
The prevalence of food sensitisation at 12 months of age determined by SPT positive
Measured: At 12 months of age
The prevalence of doctor diagnosed eczema during the first postnatal year
The prevalence of doctor diagnosed eczema during the first postnatal year
Measured: During the first postnatal year
The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit
The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit
Measured: At 12 months of age
Allergy-related healthcare utilisation within the first 12 months of life
Allergy-related healthcare utilisation within the first 12 months of life
Measured: Within the first 12 months of life
Infection episodes within the first 12 months of life
Infection episodes within the first 12 months of life
Measured: Within the first 12 months of life
Measure of height at 12 months of age
Measure of height at 12 months of age
Measured: At 12 months of age
Measure of weight at 12months of age
Measure of weight at 12months of age
Measured: At 12 months of age
Wheeze episodes within the first 12 months of life
Wheeze episodes within the first 12 months of life
Measured: Within the first 12 months of life
The occurrence of food sensitisation at 6 years of age determined by SPT positive
The occurrence of food sensitisation at 6 years of age determined by SPT positive
Measured: At 6 years of age
The occurrence of asthma in the first 6 years of life
The occurrence of asthma at 6 years of age
Measured: At 6 years of age
The occurrence of eczema in the first 6 years of life
The occurrence of eczema in the first 6 years of life
Measured: Within first 6 years of life
The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 6 years determined by measuring blood taken at the 6 year clinic visit
The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 6 years determined by measuring blood taken at the 6 year clinic visit
Measured: At 6 years of age
Allergy-related healthcare utilisation in the first 6 years of life
Allergy-related healthcare utilisation in the first 6 years of life by data linkage from MBS and PBS
Measured: Within first 6 years of life
Measure of height at 6 years of age
Measure of height at 6 years of age
Measured: At 6 years of age
Measure of Waist circumference at 6 years of age
Measure of Waist circumference at 6 years of age
Measured: At 6 years of age
Measure of Hip circumference at 6 years of age
Measure of Hip circumference at 6 years of age
Measured: At 6 years of age
Lung function at 6 years of age
Lung function: bronchial responsiveness is measured using the percent change from baseline and absolute changes in forced expiratory volume (FEV) in 1 second and/or forced vital capacity (FVC) at 6 years of age
Measured: At 6 years of age
The occurrence of rhinitis in the first 6 years of life
The occurrence of rhinitis in the first 6 years of life
Measured: Within first 6 years of life
Psychosocial Distress at 6 years of age
Psychosocial health at 6 years of age by Kessler Psychological Distress Scale-10 (K-10) for parents The K10 scale involves 10 questions about emotional states each with a five-level response scale. Each item is scored from one 'none of the time' to five 'all of the time'. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.
Measured: At 6 years of age
Psychosocial health at 6 years of age
Psychosocial health at 6 years of age by Strengths and Difficulties Questionnaire (SDQ) for child
SDQ ask about 25 attributes, some positive and others negative.bThese 25 items are divided between 5 scales:
- emotional symptoms (5 items) } 1) to 4) added together to generate a total difficulties score (based on 20 items)
- conduct problems (5 items)
- hyperactivity/inattention (5 items)
- peer relationship problems (5 items)
- prosocial behaviour (5 items)
Measured: At 6 years of age
Quality of life at 6 years of age
Quality of life (QL) at 6 years of age by Child Health Utility 9D (CHU9D, parent proxy version; PedsQL Parent Report for Young Children ages 5-7) The questionnaire has 9 questions with 5 response levels per question. The CHU9D allows the analyst to obtain quality adjusted life years (QALYs) directly for use in cost utility analysis.
Measured: At 6 years of age
Quality of life regarding Food Allergy at 6 years of age
Quality of life (QL) at 6 years of age by Food Allergy Quality of Life Questionnaires-Parent Form (FAQLQ-PF) All items are scored on a 7-point Likert scale from 0 (not at all troubled) to 6 (extremely troubled) [22]. The total scores are divided by the number of items answered, giving a range of scores from 0 to 6, with higher values indicating a poorer quality of life
Measured: At 6 years of age
Dental health at 6 years of age
Dental health at 6 years of age: A registered oral health professional will examine the participant's mouth and teeth, checking for cavities/dental decay as well as developmental mark on the teeth. In addition, a 3D scan and/or photographs of the participant's teeth will be taken to document findings.
Measured: At 6 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Perrett, MD PhD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112734
- Sponsor's protocol ID
- HREC # 34168 A
- Acronym
- VITALITY
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2014
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allen KJ, Koplin JJ, Ponsonby AL, Gurrin LC, Wake M, Vuillermin P, Martin P, Matheson M, Lowe A, Robinson M, Tey D, Osborne NJ, Dang T, Tina Tan HT, Thiele L, Anderson D, Czech H, Sanjeevan J, Zurzolo G, Dwyer T, Tang ML, Hill D, Dharmage SC. Vitamin D insufficiency is associated with challenge-proven food allergy in infants. J Allergy Clin Immunol. 2013 Apr;131(4):1109-16, 1116.e1-6. doi: 10.1016/j.jaci.2013.01.017. Epub 2013 Feb 27.
PubMed 23453797Allen KJ, Panjari M, Koplin JJ, Ponsonby AL, Vuillermin P, Gurrin LC, Greaves R, Carvalho N, Dalziel K, Tang ML, Lee KJ, Wake M, Curtis N, Dharmage SC. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health. BMJ Open. 2015 Dec 16;5(12):e009377. doi: 10.1136/bmjopen-2015-009377.
PubMed 26674499Shen Z, Robert L, Stolpman M, Che Y, Allen KJ, Saffery R, Walsh A, Young A, Eckert J, Deming C, Chen Q, Conlan S, Laky K, Li JM, Chatman L, Kashaf SS; NISC Comparative Sequencing Program; VITALITY team; Kong HH, Frischmeyer-Guerrerio PA, Perrett KP, Segre JA. A genome catalog of the early-life human skin microbiome. Genome Biol. 2023 Nov 10;24(1):252. doi: 10.1186/s13059-023-03090-w.
PubMed 37946302
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial
- ClinicalTrials.gov ID
- NCT02112734
- Acronym / sponsor ID
- VITALITY / HREC # 34168 A
- Conditions
- Food Allergy
- Keywords
- vitamin D, food allergy, eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,739 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is an urgent need to prevent the onset and progression of food allergy in our population. Evidence demonstrates that food allergy and atopic eczema represent the earliest manifestations of the atopic march with 50% of infants with food allergy predicted to develop respiratory allergic diseases later in life. 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), and have demonstrated an association between VDI and increased risk of challenge-proven food allergy in 12-month old infants, which supports numerous ecological studies showing an increased risk of food allergy the further a child resides from the equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's sunny climate, population rates of VDI have steadily increased in infants and pregnant women in parallel to the apparent rise in food allergic disease. This association is biologically plausible, as there is evidence Vitamin D is critical to the healthy development of the immune system in early life. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Active comparator | Drug: Vitamin D400 IU /daily cholecalciferol/vitamin D |
| placebo | Placebo comparator | Drug: placebocarrier formulation minus vitamin D |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: cholecalciferol400 IU/daily until age 12 months | Drug | vitamin D |
| placeboAlso: placebo is identical carrier minus vitamin Didentical placebo daily | Drug | placebo |
Primary outcome
The prevalence of challenge-proven food allergy at 12 months of age
Time frame: 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
Time frame: 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.
23 secondary outcomes
The prevalence of food sensitisation at 12 months of age determined by SPT positive
Time frame: At 12 months of age
The prevalence of doctor diagnosed eczema during the first postnatal year
Time frame: During the first postnatal year
The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit
Time frame: At 12 months of age
Allergy-related healthcare utilisation within the first 12 months of life
Time frame: Within the first 12 months of life
Infection episodes within the first 12 months of life
Time frame: Within the first 12 months of life
Measure of height at 12 months of age
Time frame: At 12 months of age
Measure of weight at 12months of age
Time frame: At 12 months of age
Wheeze episodes within the first 12 months of life
Time frame: Within the first 12 months of life
The occurrence of food sensitisation at 6 years of age determined by SPT positive
Time frame: At 6 years of age
The occurrence of asthma in the first 6 years of life
Time frame: At 6 years of age
The occurrence of eczema in the first 6 years of life
Time frame: Within first 6 years of life
The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 6 years determined by measuring blood taken at the 6 year clinic visit
Time frame: At 6 years of age
Allergy-related healthcare utilisation in the first 6 years of life
Time frame: Within first 6 years of life
Measure of height at 6 years of age
Time frame: At 6 years of age
Measure of Waist circumference at 6 years of age
Time frame: At 6 years of age
Measure of Hip circumference at 6 years of age
Time frame: At 6 years of age
Lung function at 6 years of age
Time frame: At 6 years of age
The occurrence of rhinitis in the first 6 years of life
Time frame: Within first 6 years of life
Psychosocial Distress at 6 years of age
Time frame: At 6 years of age
Psychosocial health at 6 years of age
Time frame: At 6 years of age
Quality of life at 6 years of age
Time frame: At 6 years of age
Quality of life regarding Food Allergy at 6 years of age
Time frame: At 6 years of age
Dental health at 6 years of age
Time frame: At 6 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 23453797Allen KJ, Koplin JJ, Ponsonby AL, Gurrin LC, Wake M, Vuillermin P, Martin P, Matheson M, Lowe A, Robinson M, Tey D, Osborne NJ, Dang T, Tina Tan HT, Thiele L, Anderson D, Czech H, Sanjeevan J, Zurzolo G, Dwyer T, Tang ML, Hill D, Dharmage SC. Vitamin D insufficiency is associated with challenge-proven food allergy in infants. J Allergy Clin Immunol. 2013 Apr;131(4):1109-16, 1116.e1-6. doi: 10.1016/j.jaci.2013.01.017. Epub 2013 Feb 27.
- Background: PubMed 26674499Allen KJ, Panjari M, Koplin JJ, Ponsonby AL, Vuillermin P, Gurrin LC, Greaves R, Carvalho N, Dalziel K, Tang ML, Lee KJ, Wake M, Curtis N, Dharmage SC. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health. BMJ Open. 2015 Dec 16;5(12):e009377. doi: 10.1136/bmjopen-2015-009377.
- Derived from this study: PubMed 37946302Shen Z, Robert L, Stolpman M, Che Y, Allen KJ, Saffery R, Walsh A, Young A, Eckert J, Deming C, Chen Q, Conlan S, Laky K, Li JM, Chatman L, Kashaf SS; NISC Comparative Sequencing Program; VITALITY team; Kong HH, Frischmeyer-Guerrerio PA, Perrett KP, Segre JA. A genome catalog of the early-life human skin microbiome. Genome Biol. 2023 Nov 10;24(1):252. doi: 10.1186/s13059-023-03090-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Perrett, MD PhD principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Food Allergy, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of challenge-proven food allergy at 12 months of age (time frame: At 12 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112734, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.