VITALITY: Primary prevention of infant food allergy: a randomised controlled trial of postnatal vitamin D supplementation
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 |
A/Prof Kirsten Perrett |
| 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 |
| 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 |
| Study website | mcri.edu.au/research/projects/vitality-study |
| 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) |
| Intergenerational? | No |
| Imaging | No |
| Linkage |
Medicare Benefits Schedule (MBS) |
| 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 | 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) |