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Trial registered on ANZCTR
Registration number
ACTRN12618001992291
Ethics application status
Approved
Date submitted
5/12/2018
Date registered
12/12/2018
Date last updated
15/06/2021
Date data sharing statement initially provided
12/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The Vaccination Infant Supplementation (VISS) Study - assessing the effect of vitamin D and probiotic supplementation around vaccination on infant's temperature and sleep pattern.
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Scientific title
Randomised placebo-controlled trial investigating the effect of 8 weeks supplementation with probiotics and vitamin D around routine childhood immunisation on infant's ear temperature, growth, and sleeping pattern in 4-24 month-old infants.
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Secondary ID [1]
296803
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Nil
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Universal Trial Number (UTN)
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Trial acronym
VISS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
immune function
310692
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Condition category
Condition code
Inflammatory and Immune System
309391
309391
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0
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Normal development and function of the immune system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Our study will comprise of a double-blind parallel randomised placebo-controlled trial of 8 weeks duration investigating the effect of vitamin D and probiotic supplementation around routine childhood vaccination on physiological and behavioural pattern in 4-24 month-old infants.
The active treatment group will be allocated to 1000 IU Vitamin D3 liquid supplied with a 0.25ml dropper & 2.3g Probiotic powder mixed in milk (breast milk or formula) daily for 2 months.
Each 2.3 g dose (1 level metric teaspoon) contains a blend of probiotic strains:
6 billion Lactobacillus rhamnosus (GG) organisms (LGG®)
3.75 billion Lactobacillus acidophilus (NCFM) organisms
3.75 billion Bifidobacterium lactis (Bi-07) organisms
The routine childhood vaccination - including Infanrix hexa and Prevenar 13 - will be scheduled in middle (week 4) of the 8 week supplementation regime. Supplementation will commence 4 weeks prior to vaccination (week 0) and continue 4 weeks after vaccination (week 8).
Compliance will be assessed by return of supplements, as well as diary entries.
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Intervention code [1]
313094
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Treatment: Other
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Comparator / control treatment
The Placebo group will be allocated to colour and odour-matched 0.25 ml placebo liquid and 1 metric spoon of placebo powder daily for 8 weeks.
The placebo supplements contain:
a) Placebo liquid contains medium-chain-length triglycerides
b) Placebo powder contains maize maltodextrin
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Control group
Placebo
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Outcomes
Primary outcome [1]
308348
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Tympanic ear temperature
using an infrared standard calibrated thermometer - same brand for all participants
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Assessment method [1]
308348
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Timepoint [1]
308348
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Daily 0-8 weeks at 7pm
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Secondary outcome [1]
354678
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sleep/cry pattern
diary provided for hourly recording
other symptoms to be recorded, including colds, mouth ulcers, rashes
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Assessment method [1]
354678
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Timepoint [1]
354678
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Daily 0-8 weeks
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Secondary outcome [2]
354679
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weight using calibrated infant balance scales at clinic
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Assessment method [2]
354679
0
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Timepoint [2]
354679
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0, 4, 8 weeks
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Secondary outcome [3]
354750
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infant growth: composite measure length and head circumference using infantometer (length) and tape (hc) at clinic
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Assessment method [3]
354750
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Timepoint [3]
354750
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0,4,8 weeks
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Secondary outcome [4]
354752
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carer's mood/stress: composite measure
indirect measure of infant's health
by validated Bond-Lader Questionnaire
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Assessment method [4]
354752
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Timepoint [4]
354752
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0,4,8 weeks
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Secondary outcome [5]
354753
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carer's sleep
indirect measure of infant's health
diary provided
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Assessment method [5]
354753
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Timepoint [5]
354753
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Daily 0-8 weeks
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Eligibility
Key inclusion criteria
Group 1 (preferred): Infants who have not yet been immunised (age range: 4-24 months).
Group 2: Infants who have been immunised (age range: 4-24 months).
Parents have agreed to have their child immunised.
Normal infant growth as per WHO growth charts
No tympanic temperature > 38 degrees Celsius in the preceding 4 weeks prior to immunisation
Infants currently breastfed (e.g. exclusively or breast and formula fed)
Infants currently not taking supplements (Vitamin D and/or probiotics)
Infants who will remain in the same routine with primary carers for the 2 month study period
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Minimum age
4
Months
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Maximum age
24
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Infant has any severe allergies (particularly corn or maize products, as probiotics and placebo powder contains maltodextrin)
Infant has a disease that lowers their immunity (ie. leukaemia, cancer, HIV/AIDs)
Infant is having treatment that lowers immunity (ie. steroids, immunotherapy, chemotherapy)
Infant’s mother is receiving highly immunosuppressive therapy (ie. biological disease modifying anti-rheumatic drugs (bDMARDs)
Infant has had an immunoglobulin injection, received any blood products or blood transfusion)
Infant has had a past history of Guillain-Barre syndrome
Infant has a chronic illness
Infant has a bleeding disorder
Infant is ATSI (Aboriginal Torres Strait Islander)
Infant does not have functional spleen
Infant lives with someone who is immunocompromised (ie. leukaemia, cancer, HIV/AIDS, chemotherapy)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Active and placebo drops and powder will be packaged and labelled offsite in identical numbered containers by the manufacturing company. Patients, as well as doctors and investigators will be blinded to the group allocation. Blinding success of patients will be evaluated at the end of the trial by questionnaire.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated permuted block randomisation schedule prepared by a researcher not involved in patient recruitment and data collection will be used to allocate patients to the active or placebo groups.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size & Justification
A sample size of 50 participants: Active group: Vit D + probiotic (n=25); Placebo group (n=25) suggested for this pilot study to obtain baseline values and variance for a larger study.
Analysis
Analyses will be performed using SPSS (PASW version 18). Statistical significance will be set at p<0.05. Between-group differences will be analysed by ANOVA comparing data after vaccination at 4 weeks (mean of daily data 4-8 weeks incl temperature, sleep/cry, carer sleep; or infant weight/growth data or carer mood data at 8 weeks) to data before vaccination (mean of daily data 0-4 weeks; or at 0 and 4 weeks).
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
4/02/2019
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Actual
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Date of last participant enrolment
Anticipated
12/10/2020
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Actual
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Date of last data collection
Anticipated
12/12/2020
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
25084
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3122 - Hawthorn
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Recruitment postcode(s) [2]
25085
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3123 - Hawthorn East
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Recruitment postcode(s) [3]
25086
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3124 - Camberwell
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Funding & Sponsors
Funding source category [1]
301377
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Other Collaborative groups
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Name [1]
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National Institute of Integrative Medicine
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Address [1]
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NIIM
21 Burwood Rd
Hawthorn, VIC 3122
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Country [1]
301377
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Australia
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Funding source category [2]
301407
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Commercial sector/Industry
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Name [2]
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Metagenics
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Address [2]
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741 Nudge Road
Northgate, QLD 4013
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Country [2]
301407
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Australia
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Primary sponsor type
Individual
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Name
AProf Dr Karin Ried
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Address
NIIM
21 Burwood Rd
Hawthorn, VIC 3122
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Country
Australia
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Secondary sponsor category [1]
301045
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None
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Name [1]
301045
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Address [1]
301045
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Country [1]
301045
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302115
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National Institute of Integrative Medicine Human Research Ethics Commitee
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Ethics committee address [1]
302115
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21 Burwood Rd
Hawthorn VIC 3122
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Ethics committee country [1]
302115
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Australia
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Date submitted for ethics approval [1]
302115
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23/10/2018
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Approval date [1]
302115
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28/11/2018
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Ethics approval number [1]
302115
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0047E_2018
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Summary
Brief summary
Evidence shows that Vitamin D and probiotic supplementation has a beneficial effect on a child’s immune system.
This randomised placebo controlled parallel trial aims to examine the effect of 2-month supplementation with Vitamin D and probiotics on selected physiological and behavioural responses in an infant group at time of their first routine childhood immunisation. This project will assess daily temperature and sleep pattern over two months, and growth, weight at three physician appointments, 4 weeks prior, at the time of vaccination, and 4 weeks after enrolment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Karin Ried
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Address
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NIIM
21 Burwood Rd
Hawthorn VIC 3122
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Country
89162
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Australia
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Phone
89162
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+61 3 9912 9545
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Fax
89162
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Email
89162
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[email protected]
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Contact person for public queries
Name
89163
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A/Prof Karin Ried
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Address
89163
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NIIM
21 Burwood Rd
Hawthorn VIC 3122
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Country
89163
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Australia
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Phone
89163
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+61 3 9912 9545
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Fax
89163
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Email
89163
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Karin Ried
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Address
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NIIM
21 Burwood Rd
Hawthorn VIC 3122
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Country
89164
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Australia
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Phone
89164
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+61 3 9912 9545
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Fax
89164
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Email
89164
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
individual participant data will remain anonymous, only summary data will be shared
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
626
Study protocol
376526-(Uploaded-05-12-2018-17-42-45)-Study-related document.pdf
627
Informed consent form
376526-(Uploaded-05-12-2018-17-43-02)-Study-related document.pdf
628
Ethical approval
376526-(Uploaded-05-12-2018-17-43-57)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF