VITALITY 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 3012 healthy, term, breastfed 6-8 week old infants from council-run immunisation sessions across Melbourne, Australia. Vitamin D is likely to play a role in early infant immune health, with emerging evidence that early life vitamin D deficiency increases the risk of developing childhood diseases such as food allergy, lower respiratory infections (LRIs) and eczema. 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.  An economic evaluation of the impact of the intervention from a societal perspective will also be used to model the potential cost-effectiveness of routine infant vitamin D supplementation compared to no supplementation.


Study name Primary prevention of infant food allergy: a randomised controlled trial of postnatal vitamin D supplementation
Study abbreviation VITALITY
Current principal investigator/s

A/Prof Kirsten Perrett
Prof. Mimi Tang
Dr Jennifer Koplin
Prof Anne-Louise Ponsonby
Prof. Shyamali Dharmage

Current project manager Jana Eckert
Cohort representative (study contact) Jana Eckert
Postal address Vitality Trial, Population Allergy Group, Murdoch Childrens Research Institute, The Royal Children’s Hospital, 50 Flemington Road Parkville VIC 3052
Phone +613 9936 6027
Primary Institution Murdoch Children’s Research Institute
Collaborating Institution/s The Royal Children’s Hospital; The University of Melbourne
Major funding sources National Health and Medical Research Council
Murdoch Children’s Research Institute
Philanthropic funding
Study website 
Key reference 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
Are data available outside study team? No
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 across Melbourne, Australia
Study design Participants receive either vitamin D (400 IU vitamin D3-Cholecalciferol) or placebo (vegetable oil) orally until the age of 12 months. An oral food challenge-proven food allergy is assessed at 12 months of age. Secondary outcomes are food sensitisation, number of lower respiratory infections, moderately-severe and persistent eczema and vitamin D deficiency at age 12 months. Parents are asked to complete an online questionnaire every 3 months until their child is 12 months old.
Year commenced 2014
Commencement sample

2681 as of November 2021 (intervention and placebo)
Target Sample: 3,012 (1,506 intervention, 1,506 placebo) 

Intergenerational? No 
Imaging No 

Medicare Benefits Schedule (MBS)
Pharmaceutical Benefits Scheme (PBS)
Australian Childhood Immunisation Register (ACIR)
Medical records

Biosamples? Venous blood
Newborn screening (Guthrie) card
Buccal (planned)
Saliva (planned)
Faeces (planned)
Skin swab (planned)
Breast milk (planned)


Ethics approvals or requirements? This project only (Specific consent)
Future research related to this project (Extended consent)


Wave Year Age (mean, range) Eligible sample
1  2014 – ongoing Baseline: 7.2 weeks (6.0 – 12.1 weeks) 305 (intervention and placebo) as of September 2016 (recruitment ongoing)
2  2014 – ongoing Compliance Monitoring (3-12 months)  
3  2014 – ongoing Follow-up (6 months old)  
4  2014 – ongoing Clinic visit (6 months old) Optional
5  2014 – ongoing Clinical assessment. 1.14 years (1.01 – 1.4 years) 95 (intervention and placebo) as of September 2016 (assessments ongoing)
6  2014 – ongoing Follow-up (9 months old)  
7 2014 – ongoing Follow-up (12 months old)  
8 2020 COVID Immune: Baseline (1 – 5 years)  
9 2021-ongoing COVID: 12 month follow-up (2-6 years)  
10 2021-ongoing Short Allergy Questionnaire (12-24 months)