Synopsis

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.

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 Prof. Katie Allen
Prof. Mimi Tang
Prof. Anne-Louise Ponsonby
Prof. Shyamali Dharmage
Dr. Kim Dalziel
A/Prof. Lyle Gurrin
Dr. Jennifer Koplin
Current project manager Michael Field
Cohort representative (study contact) Michael Field
Postal address Vitality Trial, Gastro & Food Allergy Group, Murdoch Childrens Research Institute, The Royal Children’s Hospital, 50 Flemington Road Parkville VIC 3052
Phone +613 9936 6027
Email vitality@mcri.edu.au
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
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 Prevention of infant food allergy
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 Current Sample: 305 (intervention and placebo) as of September 2016
Target Sample: 3,012 (1,506 intervention, 1,506 placebo) 
Intergenerational? No 
Imaging No 
Linkage

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)

Waves

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 Follow-up (6 months old)  
3  2014 – ongoing Clinic visit (6 months old)  Optional
4  2014 – ongoing Follow-up (9 months old)  
5  2015 – ongoing Follow-up (12 months old)  
6  2015 – ongoing Clinical assessment. 1.14 years (1.01 – 1.4 years) 95 (intervention and placebo) as of September 2016 (assessments ongoing)