History of Changes for Study: NCT02112734

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

Latest version (submitted November 19, 2023) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	April 10, 2014	None (earliest Version on record)
2	April 13, 2014	Arms and Interventions, Eligibility and Study Status
3	January 21, 2015	Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions, References, Oversight and Study Identification
4	September 23, 2015	Study Status
5	May 18, 2016	Contacts/Locations, Sponsor/Collaborators, Study Status, References, Eligibility, Study Design and Study Description
6	August 12, 2016	Study Status and Study Design
7	November 26, 2017	Study Status
8	May 17, 2019	Outcome Measures, Contacts/Locations, Sponsor/Collaborators, Study Status, Eligibility, Arms and Interventions and Study Design
9	May 28, 2019	Study Status and Contacts/Locations
10	October 20, 2020	Study Status and Contacts/Locations
11	March 4, 2022	Study Status and Contacts/Locations
12	November 7, 2022	Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Study Design, Study Description, Study Identification and Eligibility
13	November 19, 2023	Study Status

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Changes (Merged) for Study: NCT02112734
November 26, 2017 (v7) -- May 17, 2019 (v8)

Changes in: Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

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Study Identification


Unique Protocol ID:	HREC # 34168 A
Brief Title:	Can Vitamin D Supplementation in Infants Prevent Food Allergy in the First Year of Life? The VITALITY Trial (VITALITY)
Official Title:	Can Vitamin D Supplementation in Infants Prevent Food Allergy in the First Year of Life? The VITALITY Trial.
Secondary IDs:

Study Status


Record Verification:	November 2017 March 2019
Overall Status:	Recruiting
Study Start:	December 2014
Primary Completion:	January 2020 June 2022 [Anticipated]
Study Completion:	December 2020 2022 [Anticipated]

First Submitted:	April 10, 2014
First Submitted that Met QC Criteria:	April 10, 2014
First Posted:	April 14, 2014 [Estimate]

Last Update Submitted that Met QC Criteria:	November 26, 2017 May 17, 2019
Last Update Posted:	November 28 May 21, 2017 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Murdoch Childrens Research Institute
Responsible Party:	Principal Investigator Sponsor Investigator: Katrina Allen Official Title: Prof Katrina Allen Affiliation: Murdoch Childrens Research Institute
Collaborators:

Study Description

Brief Summary:

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 IgE-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. 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:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 4
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	3012 3555 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: vitamin D 400 IU /daily cholecalciferol/vitamin D	Drug: Vitamin D 400 IU/daily for 10 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

Outcome Measures


Primary Outcome Measures:
1.	the prevalence and severity of challenge-proven food allergy in study participants with positive skin prick tests (SPT) The prevalence of challenge-proven food allergy at 12 months of age determined by both positive SPT and positive oral food challenge [ Time Frame: at age 12 months At 12 months of age ] The prevalence of challenge-proven food allergy at 12 months of age determined by both positive SPT and positive oral food challenge
Secondary Outcome Measures:
1.	prevalence of food sensitisation (positive skin prick) test The prevalence of food sensitisation at 12 months of age determined by SPT positive [ Time Frame: age 12 months At 12 months of age ] The prevalence of food sensitisation at 12 months of age determined by SPT positive
2.	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
3.	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
4.	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
Other Outcome Measures:
1 .	doctor diagnosed eczema during the first postnatal year [ Time Frame: age 12 months ]
2 .	vitamin D insufficiency [ Time Frame: at age 12 months ]

Eligibility


Minimum Age:	6 Weeks
Maximum Age:	8 12 Weeks
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	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. -Healthy, term, breastfeeding infants who will be predominately breastfed for at least 6-months. This will be determined by answering yes/no to question 'do you intend to breastfeed until your infant is at least 6 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/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. Infants who have already received postnatal vitamin D supplementation prematurity (<37 weeks)/low birthweight <2500 g poor health due to a current or past significant disease state or congenital abnormality.

Contacts/Locations


Central Contact Person:	Michael Field Telephone: 613 99366027 Email: michael.field vitality@mcri.edu.au
Central Contact Backup:	Jennifer Koplin Email: jennifer.koplin@mcri.edu.au
Study Officials:	Katie Allen, PhD Kirsten Perrett, MD PhD Principal Investigator MCRI On-X Life Technologies, Inc.
Locations:	Australia, Victoria
	Murdoch Childrens Research Institute [Recruiting] Melbourne, Victoria, Australia, 3052

References


Citations:	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 23453797
	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. PubMed 26674499
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