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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02112734




Registration number
NCT02112734
Ethics application status
Date submitted
10/04/2014
Date registered
14/04/2014
Date last updated
21/11/2023

Titles & IDs
Public title
Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2
Scientific title
Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial
Secondary ID [1] 0 0
HREC # 34168 A
Universal Trial Number (UTN)
Trial acronym
VITALITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vitamin D
Treatment: Drugs - placebo

Active Comparator: vitamin D - 400 IU /daily cholecalciferol/vitamin D

Placebo Comparator: placebo - carrier formulation minus vitamin D


Treatment: Drugs: Vitamin D
400 IU/daily until age 12 months

Treatment: Drugs: placebo
identical placebo daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The prevalence of challenge-proven food allergy at 12 months of age
Timepoint [1] 0 0
At 12 months of age
Primary outcome [2] 0 0
The occurrence of definite food allergy or tolerance at 6 years of age
Timepoint [2] 0 0
At 6 years of age
Secondary outcome [1] 0 0
The prevalence of food sensitisation at 12 months of age determined by SPT positive
Timepoint [1] 0 0
At 12 months of age
Secondary outcome [2] 0 0
The prevalence of doctor diagnosed eczema during the first postnatal year
Timepoint [2] 0 0
During the first postnatal year
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
At 12 months of age
Secondary outcome [4] 0 0
Allergy-related healthcare utilisation within the first 12 months of life
Timepoint [4] 0 0
Within the first 12 months of life
Secondary outcome [5] 0 0
Infection episodes within the first 12 months of life
Timepoint [5] 0 0
Within the first 12 months of life
Secondary outcome [6] 0 0
Measure of height at 12 months of age
Timepoint [6] 0 0
At 12 months of age
Secondary outcome [7] 0 0
Measure of weight at 12months of age
Timepoint [7] 0 0
At 12 months of age
Secondary outcome [8] 0 0
Wheeze episodes within the first 12 months of life
Timepoint [8] 0 0
Within the first 12 months of life
Secondary outcome [9] 0 0
The occurrence of food sensitisation at 6 years of age determined by SPT positive
Timepoint [9] 0 0
At 6 years of age
Secondary outcome [10] 0 0
The occurrence of asthma in the first 6 years of life
Timepoint [10] 0 0
At 6 years of age
Secondary outcome [11] 0 0
The occurrence of eczema in the first 6 years of life
Timepoint [11] 0 0
Within first 6 years of life
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
At 6 years of age
Secondary outcome [13] 0 0
Allergy-related healthcare utilisation in the first 6 years of life
Timepoint [13] 0 0
Within first 6 years of life
Secondary outcome [14] 0 0
Measure of height at 6 years of age
Timepoint [14] 0 0
At 6 years of age
Secondary outcome [15] 0 0
Measure of Waist circumference at 6 years of age
Timepoint [15] 0 0
At 6 years of age
Secondary outcome [16] 0 0
Measure of Hip circumference at 6 years of age
Timepoint [16] 0 0
At 6 years of age
Secondary outcome [17] 0 0
Lung function at 6 years of age
Timepoint [17] 0 0
At 6 years of age
Secondary outcome [18] 0 0
The occurrence of rhinitis in the first 6 years of life
Timepoint [18] 0 0
Within first 6 years of life
Secondary outcome [19] 0 0
Psychosocial Distress at 6 years of age
Timepoint [19] 0 0
At 6 years of age
Secondary outcome [20] 0 0
Psychosocial health at 6 years of age
Timepoint [20] 0 0
At 6 years of age
Secondary outcome [21] 0 0
Quality of life at 6 years of age
Timepoint [21] 0 0
At 6 years of age
Secondary outcome [22] 0 0
Quality of life regarding Food Allergy at 6 years of age
Timepoint [22] 0 0
At 6 years of age
Secondary outcome [23] 0 0
Cardiovascular health (vascular function) at 6 years of age
Timepoint [23] 0 0
At 6 years of age
Secondary outcome [24] 0 0
Cardiovascular health (Carotid and aortic Intima-Media Thickness) at 6 years of age
Timepoint [24] 0 0
At 6 years of age
Secondary outcome [25] 0 0
Cardiovascular health (Blood pressure) at 6 years of age
Timepoint [25] 0 0
At 6 years of age
Secondary outcome [26] 0 0
Cardiovascular health (Arterial stiffness) at 6 years of age
Timepoint [26] 0 0
At 6 years of age
Secondary outcome [27] 0 0
Dental health at 6 years of age
Timepoint [27] 0 0
At 6 years of age
Secondary outcome [28] 0 0
Hearing health at 6 years of age
Timepoint [28] 0 0
At 6 years of age

Eligibility
Key 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.
Minimum age
6 Weeks
Maximum age
12 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
Accrual to date
Final
2739
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Childrens Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02112734
Trial related presentations / 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.
Allen 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.
Public notes

Contacts
Principal investigator
Name 0 0
Kirsten Perrett, MD PhD
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries