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Trial registered on ANZCTR
Registration number
ACTRN12609000486224
Ethics application status
Approved
Date submitted
10/06/2009
Date registered
18/06/2009
Date last updated
18/05/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of vitamin D supplementation on upper respiratory infections in adults
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Scientific title
In healthy adults, is vitamin D supplementation better than placebo for preventing and/or reducing the severity of upper respiratory tract infections?
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Secondary ID [1]
252119
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HRC 09/302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Upper respiratory tract infections
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Condition category
Condition code
Infection
237316
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Vitamin D3 200,000 IU oral tablet at baseline, then 200,000 IU oral tablet one month later, then 100,000 IU oral tablet monthly for 18 months.
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Intervention code [1]
236742
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Prevention
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Comparator / control treatment
Placebo (matching sugar pill) - 335 mg oral tablets taken monthly for 18 months starting 1 month after initial loading doses at baseline and 1 month later.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Incidence rate of upper respiratory tract infections as assessed by questionnaires.
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Assessment method [1]
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Timepoint [1]
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18 months after randomisation
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Secondary outcome [1]
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Severity of upper respiratory tract infections (mean sum of Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) scores over 7 days from the onset of symptoms)
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Assessment method [1]
242337
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Timepoint [1]
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18 months after randomisation
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Secondary outcome [2]
242338
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Number of days off work due to upper respiratory tract infections as assessed by questionnaires.
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Assessment method [2]
242338
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Timepoint [2]
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18 months after randomisation
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Secondary outcome [3]
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Resting bood pressure, measured in a seated position with an automatic shygmomanometer
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Assessment method [3]
297493
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Timepoint [3]
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Baseline, 5 months and 18 months
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Secondary outcome [4]
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Staphylococcus aureus nasal carriage by culture of nasal swabs.
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Assessment method [4]
297494
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Timepoint [4]
297494
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Baseline, 6 months, 12 months and 18 months
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Secondary outcome [5]
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Dandruff/dry scalp by participant reports.
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Assessment method [5]
297495
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Timepoint [5]
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Baseline and 5 months
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Eligibility
Key inclusion criteria
Age 18 years and over, ability to give informed consent, anticipated residence in Christchurch for the 18-month study period
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Minimum age
18
Years
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Maximum age
No limit
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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
Use of vitamin D3 supplements, pregnancy, use of immunosuppressants or medications that interfere with vitamin D metabolism, history of hypercalcaemia, nephrolithiasis or sarcoidosis, and current kidney or liver disorders, malignancy and malabsorption.
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
22/02/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
320
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
1831
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
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Level 3, 110 Stanley Street, Auckland 1010
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Country [1]
237137
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
P.O. Box 4345, Christchurch 8140
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Country
New Zealand
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Secondary sponsor category [1]
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University
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Name [1]
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University of Auckland
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Address [1]
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P.O. Box 92019, Auckland 1142
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Country [1]
4628
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New Zealand
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Other collaborator category [1]
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Hospital
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Name [1]
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Canterbury Health Laboratories
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Address [1]
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P.O. Box 151, Christchurch 8011
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Country [1]
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics committee address [1]
239230
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Ethics committee country [1]
239230
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Date submitted for ethics approval [1]
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30/06/2009
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Approval date [1]
239230
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Ethics approval number [1]
239230
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Summary
Brief summary
The main hypothesis of the study is that maintaining an adequate vitamin D level will prevent and/or reduce the severity of upper respiratory infections.
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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
29728
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David Murdoch
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Address
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University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
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Country
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New Zealand
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Phone
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+64 3 364 0590
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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David Murdoch
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Address
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University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
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Country
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New Zealand
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Phone
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+64 3 364 0590
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Fax
3903
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Dimensions AI
Effect of vitamin D3 supplementation on Staphylococcus aureus nasal carriage: a randomized, double-blind, placebo-controlled trial in healthy adults
2013
https://doi.org/10.1111/1469-0691.12350
Embase
Vitamin D modulation of innate immune responses to respiratory viral infections.
2017
https://dx.doi.org/10.1002/rmv.1909
N.B. These documents automatically identified may not have been verified by the study sponsor.
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