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

November 25, 2025 updated by: Murdoch Childrens Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2739

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Murdoch Childrens Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: vitamin D
400 IU /daily cholecalciferol/vitamin D
Drug: Vitamin D
400 IU/daily until age 12 months
Other Names:
  • cholecalciferol
Placebo Comparator: placebo
carrier formulation minus vitamin D
Drug: placebo
identical placebo daily
Other Names:
  • placebo is identical carrier minus vitamin D

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At 12 months of age
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.
At 6 years of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The prevalence of food sensitisation at 12 months of age determined by SPT positive
Time Frame: At 12 months of age
The prevalence of food sensitisation at 12 months of age determined by SPT positive
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 doctor diagnosed eczema during the first postnatal year
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
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
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
Allergy-related healthcare utilisation within the first 12 months of life
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
Infection episodes within the first 12 months of life
Within the first 12 months of life
Measure of height at 12 months of age
Time Frame: At 12 months of age
Measure of height at 12 months of age
At 12 months of age
Measure of weight at 12months of age
Time Frame: At 12 months of age
Measure of weight at 12months of age
At 12 months of age
Wheeze episodes within the first 12 months of life
Time Frame: Within the first 12 months of life
Wheeze episodes within the first 12 months of life
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 food sensitisation at 6 years of age determined by SPT positive
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 asthma at 6 years of age
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 occurrence of eczema in the first 6 years of life
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
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
At 6 years of age
Allergy-related healthcare utilisation in the first 6 years of life
Time Frame: Within first 6 years of life
Allergy-related healthcare utilisation in the first 6 years of life by data linkage from MBS and PBS
Within first 6 years of life
Measure of height at 6 years of age
Time Frame: At 6 years of age
Measure of height at 6 years of age
At 6 years of age
Measure of Waist circumference at 6 years of age
Time Frame: At 6 years of age
Measure of Waist circumference at 6 years of age
At 6 years of age
Measure of Hip circumference at 6 years of age
Time Frame: At 6 years of age
Measure of Hip circumference at 6 years of age
At 6 years of age
Lung function at 6 years of age
Time Frame: 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
At 6 years of age
The occurrence of rhinitis in the first 6 years of life
Time Frame: Within first 6 years of life
The occurrence of rhinitis in the first 6 years of life
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 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.
At 6 years of age
Psychosocial health at 6 years of age
Time Frame: 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:

  1. emotional symptoms (5 items) } 1) to 4) added together to generate a total difficulties score (based on 20 items)
  2. conduct problems (5 items)
  3. hyperactivity/inattention (5 items)
  4. peer relationship problems (5 items)
  5. prosocial behaviour (5 items)
At 6 years of age
Quality of life at 6 years of age
Time Frame: 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.
At 6 years of age
Quality of life regarding Food Allergy at 6 years of age
Time Frame: 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
At 6 years of age
Dental health at 6 years of age
Time Frame: 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.
At 6 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Murdoch Childrens Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kirsten Perrett, MD PhD, Murdoch Childrens Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREC # 34168 A

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