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Trial registered on ANZCTR


Registration number
ACTRN12612000787886
Ethics application status
Approved
Date submitted
18/07/2012
Date registered
25/07/2012
Date last updated
21/02/2020
Date data sharing statement initially provided
11/03/2019
Date results provided
21/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of vitamin D supplementation in infancy on immune development
Scientific title
In infants with a family history of allergic disease, vitamin D supplementation from birth to 6 months of age will be compared to no vitamin D supplementation on the outcomes of infant vitamin D status and immune function.
Secondary ID [1] 280871 0
Nil
Universal Trial Number (UTN)
Trial acronym
VITAL Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Disease 286943 0
Condition category
Condition code
Inflammatory and Immune System 287279 287279 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
400 IU per day of vitamin D3-Cholecalciferol contained within coconut and palm kernel oil and to be given to the infant as one drop of liquid (0.03ml) per day from birth to 6 months of age.
Intervention code [1] 285307 0
Prevention
Comparator / control treatment
Coconut and palm kernel oil are to be given to the infant as one drop of liquid (0.03ml) per day from birth to 6 months of age.
Control group
Placebo

Outcomes
Primary outcome [1] 287559 0
Immune function will be assessed using infant mononuclear cells cultured in serum free medium, either alone or in the presence of food allergens, inhalant allergens or bacterial antigens or mitogens (PHA). Cytokines (IL-5, IL-6, IL-10, IL-13, IL-17, TNF and IFN-gamma) will be measured in the supernatants after 48 hours. This will include a range of cytokines to assess the pattern of cellular response to these stimuli (above), including production of T helper cell type 1 (Th1) cytokine (IFN-gamma), pro-allergic Th2 cytokines (Il-5 and IL-13), regulatory cytokines (IL-10) and an inflammatory cytokines (IL-6). Cytokines will be measured by Luminex multiplexing technology (Austin, Texas, USA).
Timepoint [1] 287559 0
At 6 months of age.
Primary outcome [2] 287560 0
Vitamin D status measured via serum assay.
Timepoint [2] 287560 0
At 6 months of age.
Secondary outcome [1] 298389 0
Immune function will be assessed using infant mononuclear cells cultured in serum free medium, either alone or in the presence of food allergens, inhalant allergens or bacterial antigens or mitogens (PHA). Cytokines (IL-5, IL-6, IL-10, IL-13, IL-17, TNF and IFN-gamma) will be measured in the supernatants after 48 hours. This will include a range of cytokines to assess the pattern of cellular response to these stimuli (above), including production of T helper cell type 1 (Th1) cytokine (IFN-gamma), pro-allergic Th2 cytokines (Il-5 and IL-13), regulatory cytokines (IL-10) and an inflammatory cytokines (IL-6). Cytokines will be measured by Luminex multiplexing technology (Austin, Texas, USA).
Timepoint [1] 298389 0
At 12 months of age.
Secondary outcome [2] 298390 0
Vitamin D status measured via serum assay.
Timepoint [2] 298390 0
At 3 and 12 months of age.
Secondary outcome [3] 298391 0
Effects on parameters of bone metabolism. Calcium, phosphate and alkaline phosphatase measured via serum assay.
Timepoint [3] 298391 0
At 3, 6 and 12 months of age.
Secondary outcome [4] 298392 0
Stool samples will be frozen and assayed to measure eosinophilic cationic protein (ECP) and secretory immunoglobulin A (sIgA), as measures of local gut inflammation and immune function.
Timepoint [4] 298392 0
At 6 months of age.
Secondary outcome [5] 298393 0
Allergic disease (eczema and/or food allergy) will be determined by completion of standardised interview-administered questions and the child will be examined for signs of allergic disease (ie eczema).
Timepoint [5] 298393 0
At 6, 12 and 30 months of age.
Secondary outcome [6] 298394 0
Sensitisation to food and aero allergens. The child will have allergy skin prick testing (SPT) to determine sensitisation status to common food (wheat, egg, cow's milk, peanut, cashew nut, fish) and aeroallergens (rye grass pollen, cat and house dust mite {D. pteronyssinus}) with histamine and control solutions in accordance with standard clinical methods as outlined in the 2009 ASCIA Skin Prick Testing for the Diagnosis of Allergic Disease: A manual for practitioners.
Timepoint [6] 298394 0
At 12 and 30 months of age.
Secondary outcome [7] 298395 0
Infant sun (UV light) exposure levels will be measured using UV detector clips worn daily from birth to 6 months of age.
Timepoint [7] 298395 0
At 3 and 6 months of age.

Eligibility
Key inclusion criteria
Term singleton infants who have a first degree relative with a history of allergic disease.
Minimum age
0 Months
Maximum age
1 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternal vitamin D serum concentration <50 nmol/L or >100 nmol/L between 36-40 weeks gestation.
Maternal smoking during pregnancy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Written informed consent will be obtained before participation in a screening appointment to establish trial eligibility. Each participating infant will be assigned an unique study number and randomly allocated into one of two intervention groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule will be produced by an independent consultant. The schedule will be stratified by infant sex and maternal history of allergic disease status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2012
Actual
9/10/2012
Date of last participant enrolment
Anticipated
10/04/2017
Actual
23/01/2017
Date of last data collection
Anticipated
29/03/2019
Actual
31/01/2019
Sample size
Target
200
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1096 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 6951 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 285660 0
Charities/Societies/Foundations
Name [1] 285660 0
Asthma Foundation WA
Country [1] 285660 0
Australia
Funding source category [2] 288877 0
Government body
Name [2] 288877 0
Telethon-New Children’s Hospital Research Fund
Government of Western Australia
Department of Health
Country [2] 288877 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Department of Paediatrics and Child Health
University of Western Australia
Roberts Rd
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 284497 0
None
Name [1] 284497 0
Address [1] 284497 0
Country [1] 284497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287656 0
The Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 287656 0
Ethics committee country [1] 287656 0
Australia
Date submitted for ethics approval [1] 287656 0
Approval date [1] 287656 0
02/07/2012
Ethics approval number [1] 287656 0
1959/EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34456 0
Dr Debbie Palmer
Address 34456 0
Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave Nedlands WA 6009
Country 34456 0
Australia
Phone 34456 0
+61 8 6319 1750
Fax 34456 0
Email 34456 0
debbie.palmer@telethonkids.org.au
Contact person for public queries
Name 17703 0
Debbie Palmer
Address 17703 0
Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave Nedlands WA 6009
Country 17703 0
Australia
Phone 17703 0
+61 8 6319 1750
Fax 17703 0
+61 8 9388 2097
Email 17703 0
debbie.palmer@telethonkids.org.au
Contact person for scientific queries
Name 8631 0
Debbie Palmer
Address 8631 0
Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave Nedlands WA 6009
Country 8631 0
Australia
Phone 8631 0
+61 8 6319 1750
Fax 8631 0
+61 8 9388 2097
Email 8631 0
debbie.palmer@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, individual participant data underlying published results only.
When will data be available (start and end dates)?
Beginning 6 months after and ending 5 years following main results publication.
Available to whom?
Case by case basis at the discretion of CI Debbie Palmer
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by CI Debbie Palmer


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIn "high-risk" infants with sufficient vitamin d status at birth, infant vitamin D supplementation had no effect on allergy outcomes: A randomized controlled trial.2020https://dx.doi.org/10.3390/nu12061747
EmbaseIn infants with sufficient vitamin D status at birth, vitamin D supplementation does not impact immune development.2020https://dx.doi.org/10.1111/pai.13250
EmbaseThe influence of sunlight exposure and sun protecting behaviours on allergic outcomes in early childhood.2021https://dx.doi.org/10.3390/ijerph18105429
N.B. These documents automatically identified may not have been verified by the study sponsor.