Trial registered on ANZCTR


Trial ID
ACTRN12609000486224
Ethics application status
Approved
Date submitted
10/06/2009
Date registered
18/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of vitamin D supplementation on upper respiratory infections in adults
Scientific title
In healthy adults, is vitamin D supplementation better than placebo for preventing and/or reducing the severity of upper respiratory tract infections?
Secondary ID [1] 252119 0
HRC 09/302
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Upper respiratory tract infections 236969 0
Condition category
Condition code
Infection 237316 237316 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 236742 0
Prevention
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.
Control group
Placebo

Outcomes
Primary outcome [1] 238130 0
Incidence rate of upper respiratory tract infections as assessed by questionnaires.
Timepoint [1] 238130 0
18 months after randomisation
Secondary outcome [1] 242337 0
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)
Timepoint [1] 242337 0
18 months after randomisation
Secondary outcome [2] 242338 0
Number of days off work due to upper respiratory tract infections as assessed by questionnaires.
Timepoint [2] 242338 0
18 months after randomisation
Secondary outcome [3] 297493 0
Resting bood pressure, measured in a seated position with an automatic shygmomanometer
Timepoint [3] 297493 0
Baseline, 5 months and 18 months
Secondary outcome [4] 297494 0
Staphylococcus aureus nasal carriage by culture of nasal swabs.
Timepoint [4] 297494 0
Baseline, 6 months, 12 months and 18 months
Secondary outcome [5] 297495 0
Dandruff/dry scalp by participant reports.
Timepoint [5] 297495 0
Baseline and 5 months

Eligibility
Key inclusion criteria
Age 18 years and over, ability to give informed consent, anticipated residence in Christchurch for the 18-month study period
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)

Recruitment
Anticipated date of first participant enrolment
22/02/2010
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
320
Actual sample size
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1831 0
New Zealand
State/province [1] 1831 0

Funding & Sponsors
Funding source category [1] 237137 0
Government body
Name [1] 237137 0
Health Research Council of New Zealand
Address [1] 237137 0
Level 3, 110 Stanley Street, Auckland 1010
Country [1] 237137 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
P.O. Box 4345, Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 4628 0
University
Name [1] 4628 0
University of Auckland
Address [1] 4628 0
P.O. Box 92019, Auckland 1142
Country [1] 4628 0
New Zealand
Other collaborator category [1] 707 0
Hospital
Name [1] 707 0
Canterbury Health Laboratories
Address [1] 707 0
P.O. Box 151, Christchurch 8011
Country [1] 707 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239230 0
Ethics committee address [1] 239230 0
Ethics committee country [1] 239230 0
Date submitted for ethics approval [1] 239230 0
30/06/2009
Approval date [1] 239230 0
Ethics approval number [1] 239230 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29728 0
Address 29728 0
Country 29728 0
Phone 29728 0
Fax 29728 0
Email 29728 0
Contact person for public queries
Name 12975 0
David Murdoch
Address 12975 0
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
Country 12975 0
New Zealand
Phone 12975 0
+64 3 364 0590
Fax 12975 0
Email 12975 0
david.murdoch@cdhb.govt.nz
Contact person for scientific queries
Name 3903 0
David Murdoch
Address 3903 0
University of Otago, Christchurch
P.O. Box 4345
Christchurch 8140
Country 3903 0
New Zealand
Phone 3903 0
+64 3 364 0590
Fax 3903 0
Email 3903 0
david.murdoch@cdhb.govt.nz