Primary prevention of infant food allergy: a randomised controlled trial of postnatal vitamin D supplementation (VITALITY)

VITALITY (Primary prevention of infant food allergy: a randomised controlled trial of postnatal vitamin D supplementation) is a double-blind, randomised, placebo-controlled trial assessing the role of postnatal vitamin D supplementation for the prevention of infant food allergy. Recruitment began in December 2014, and is planning on recruiting 3055 healthy, term, breastfed 6-8 week old infants from council-run immunisation sessions across Melbourne, Australia.

VITALITY aims to determine if vitamin D supplementation leads to a reduction in challenge-proven food allergy, LRIs, food sensitisation, doctor diagnosed eczema, and vitamin D deficiency in the first year of life; with the ultimate goal being to develop improved public health guidelines for vitamin D supplementation of infants.

Year 2014-Ongoing 2014-Ongoing 2014-Ongoing 2014-Ongoing 2014-Ongoing 2020 2014-Ongoing 2014-Ongoing 2021-Ongoing 2021-Ongoing
Phase Baseline Compliance Monitoring 6 month follow-up Optional Clinic Visit Clinical assessment COVID Immune: Baseline 9 month follow-up 12 month follow-up COVID Immune: 12 month follow-up Short Allergy Questionnaire
Age 6-12 weeks 3-12 months 6 months 6 months 12-18 months 1-5 years 9 months 12 months 2-6 years 12-24 months
N in progress in progress in progress in progress in progress in progress in progress in progress in progress
RELEVANT LIFECOURSE DOMAINS Allergies Allergies Allergies Allergies
Anthropometrics Anthropometrics
Bioanalyses and omics
Biosamples Biosamples Biosamples
Cardiovascular health
Demographics Demographics
Education and childcare Education and childcare Education and childcare
Environmental exposures Environmental exposures Environmental exposures Environmental exposures
Family environment Family environment Family environment
Health services Health services
Medications and supplements Medications and supplements
Mental health and behaviour problems Mental health and behaviour problems
Methodology
Neurocognitive development Neurocognitive development
Nutrition Nutrition Nutrition Nutrition Nutrition
Other health information Other health information Other health information
Peer relationships Peer relationships
Physical appearance
Pregnancy and birth Pregnancy and birth Pregnancy and birth
Psychosocial wellbeing Psychosocial wellbeing
Puberty Puberty
Respiratory health Respiratory health Respiratory health Respiratory health
Romantic relationships Romantic relationships
Sleep Sleep Sleep
Substance use Substance use
Study Summary
Study name Primary prevention of infant food allergy: a randomised controlled trial of postnatal vitamin D supplementation
Study abbreviation VITALITY
Current principal investigator/s Kirsten Perrett
Mimi Tang
A/Prof Jennifer Koplin (MCRI)
Prof Anne-Louise Ponsonby (MCRI)
Shyamali Dharmage
Current project manager

Jana Eckert
Primary Institution/s Murdoch Children’s Research Institute - MCRI
Collaborating Institution/s The Royal Children’s Hospital - RCH
The University of Melbourne - UoM
Major funding source/s National Health and Medical Research Council - NHMRC
The National Institute of Allergy and Infectious Diseases
Murdoch Children’s Research Institute - MCRI
Philanthropic funding
Study website https://www.mcri.edu.au/research/projects/vitality-study
Key reference for study Allen, K.J., Panjari, M., Koplin, J.J., Ponsonby, A.-L., Vuillermin, P., Gurrin, L.C., Greaves, R., Carvalho, N., Dalziel, K., Tang, M.L., Lee, K.J., Wake, M., Curtis, N. and Dharmage, S.C. (2015). VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health. BMJ Open, 5(12): p. e009377. doi: 10.1136/bmjopen-2015-009377
Study focus

To assess the role of postnatal vitamin D supplementation for the prevention of infant food allergy, lower respiratory infections (LRIs) and eczema

 
Sampling frame

Randomly-selected council-run immunisation sessions, maternal and child health nurse sessions, and online across Melbourne, Australia

 
Primary study type Randomised Control Trial / Other trial
Primary participant (at recruitment) Index child
Year commenced

2014

 
Is this study ongoing? Yes - the study is ongoing
Ongoing recruitment? Yes
Sample size (N)

2681 as of November 2021 (intervention and placebo)

 
Survey data available? Yes
Imaging data available? No
Linkage to administrative dataset/s? Yes, linkage to (at least one) administrative dataset underway
Biosamples available? Yes
Are data available to others outside study team, with appropriate safeguards and structures in line with the cohort’s ethics and governance processes? Yes
Are there any costs associated with data/sample access for approved requests? There may be costs associated with access, evaluated on a case by case basis
Broadest type of participant consent available Extended consent (can be used for future ethically approved research related to this project)
Phase Year Age Sample size (N)
Baseline 2014-Ongoing 6-12 weeks IN PROGRESS
Compliance Monitoring 2014-Ongoing 3-12 months IN PROGRESS
6 month follow-up 2014-Ongoing 6 months IN PROGRESS
Optional Clinic Visit 2014-Ongoing 6 months IN PROGRESS
Clinical assessment 2014-Ongoing 12-18 months IN PROGRESS
COVID Immune: Baseline 2020 1-5 years
9 month follow-up 2014-Ongoing 9 months IN PROGRESS
12 month follow-up 2014-Ongoing 12 months IN PROGRESS
COVID Immune: 12 month follow-up 2021-Ongoing 2-6 years IN PROGRESS
Short Allergy Questionnaire 2021-Ongoing 12-24 months IN PROGRESS
Study Contacts
Principal investigator/s Kirsten Perrett
Mimi Tang
A/Prof Jennifer Koplin (MCRI)
Prof Anne-Louise Ponsonby (MCRI)
Shyamali Dharmage
Project manager

Jana Eckert
Study Contact

Ph: +613 9936 6027
Email: vitality@mcri.edu.au
Address: VITALITY Trial
Population Allergy Group
Murdoch Children's Research Institute,
Royal Children’s Hospital
Flemington Road, Parkville
Victoria 3052 Australia