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. 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 Jennifer Koplin Anne-Louise Ponsonby 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)

Study Contacts
Principal investigator/s	Kirsten Perrett Mimi Tang Jennifer Koplin Anne-Louise Ponsonby Shyamali Dharmage
Project manager	Jana Eckert
Study Contact	Ph: +613 9936 6027 Email: [email protected] Address: VITALITY Trial Population Allergy Group Murdoch Children's Research Institute, Royal Children’s Hospital Flemington Road, Parkville Victoria 3052 Australia