LifeCourse A Melbourne Children's Research Initiative

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. Beginning in December 2014, VITALITY recruited 2,739 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	2014-2022	2014-2023	2014-2023	2014-2023	2020	2014-2023	2014-2023	2021	2021-2023	2014-2023	2023-Ongoing	2023-Ongoing
Phase	Baseline	Compliance Monitoring	6 month follow-up	Optional Clinic Visit	COVID Immune: Baseline	9 month follow-up	12 month follow-up	COVID Immune: 12 month follow-up	Short Allergy Questionnaire	12mth Clinical assessment	6 year follow up	6 year Clinic assessment
Age	6-12 weeks	3-12 months	6 months	6 months	1-5 years	9 months	12 months	2-6 years	12-24 months	12-18 months	6-7 years	6-7 years
N	2739										in progress	in progress
RELEVANT LIFECOURSE DOMAINS	Allergies		Allergies			Allergies			Allergies
	Anthropometrics			Anthropometrics						Anthropometrics
										Bioanalyses and omics		Bioanalyses and omics
	Biosamples			Biosamples				Biosamples		Biosamples		Biosamples
										Cardiovascular health		Cardiovascular health
	Demographics		Demographics							Demographics
	Education and childcare		Education and childcare		Education and childcare						Education and childcare
	Environmental and climate exposures		Environmental and climate exposures		Environmental and climate exposures		Environmental and climate exposures				Environmental and climate exposures
	Family environment				Family environment			Family environment			Family environment
	Health services		Health services							Health services
											Hearing
	Medications and supplements					Medications and supplements				Medications and supplements
					Mental health and behaviour problems			Mental health and behaviour problems			Mental health and behaviour problems
	Methodology									Methodology
			Neurocognitive development			Neurocognitive development					Neurocognitive development
	Nutrition		Nutrition			Nutrition			Nutrition
											Oral health
	Other health information		Other health information		Other health information					Other health information
					Peer relationships			Peer relationships			Peer relationships
											Physical activity
										Physical appearance
	Pregnancy and birth		Pregnancy and birth			Pregnancy and birth					Pregnancy and birth
					Psychosocial wellbeing			Psychosocial wellbeing			Psychosocial wellbeing
	Respiratory health		Respiratory health			Respiratory health				Respiratory health
					Romantic relationships			Romantic relationships
	Sleep		Sleep			Sleep				Sleep
											Speech and language
	Substance use						Substance use				Substance use
										Vision

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 Rachel Peters Katie Allen Shyamali Dharmage Sarath Ranganathan Jennifer Koplin Katherine Lee Adrian Lowe Mimi Tang Victoria Soriano Anne-Louise Ponsonby Richard Saffery David Burgner Li Huang
Current project manager	Jana Eckert Deborah Anderson
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
Year commenced	2014
Is this study ongoing?	Yes - the study is ongoing
Ongoing recruitment?	No
Sample size (N)	2739 as of April 2022 (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)

2023

Shen Z, Robert L, Stolpman M, Che Y, Allen KJ, Saffery R, Walsh A, Young A, Eckert J, Deming C, Chen Q, Conlan S, Laky K, Li JM, Chatman L, Kashaf SS, NISC Comparative Sequencing Program , VITALITY team , Kong HH, Frischmeyer-Guerrerio PA, Perrett KP, Segre JA. (2023). A genome catalog of the early-life human skin microbiome. Genome Biol, 24(1), 252. DOI: 10.1186/s13059-023-03090-w

2015

Allen KJ, Panjari M, Koplin JJ, Ponsonby A-L, Vuillermin P, Gurrin LC, Greaves R, Carvalho N, Dalziel K, Tang MLK, Lee KJ, Wake M, Curtis N, Dharmage SC. (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), e009377. DOI: 10.1136/bmjopen-2015-009377

Study Contacts
Principal investigator/s	Kirsten Perrett Rachel Peters Katie Allen Shyamali Dharmage Sarath Ranganathan Jennifer Koplin Katherine Lee Adrian Lowe Mimi Tang Victoria Soriano Anne-Louise Ponsonby Richard Saffery David Burgner Li Huang
Project manager	Jana Eckert Deborah Anderson
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