Trial from ANZCTR


Trial ID ACTRN12609000486224
Trial Status: Registered
Date Submitted: 10/06/2009
Date Registered: 18/06/2009
Prospectively registered

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Public title Effect of vitamin D supplementation on upper respiratory infections in adults
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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 0
HRC 09/302
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Upper respiratory tract infections 236969 0
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Infection Other infectious diseases
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237316 237316 0 0

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Descriptions 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:
Prevention 236742 0
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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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Primary Outcome: Incidence rate of upper respiratory tract infections as assessed by questionnaires. 238130 0
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Timepoint: 18 months after randomisation 238130 0
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Secondary Outcome: 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) 242337 0
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Timepoint: 18 months after randomisation 242337 0
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Secondary Outcome: Number of days off work due to upper respiratory tract infections as assessed by questionnaires. 242338 0
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Timepoint: 18 months after randomisation 242338 0
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Secondary Outcome: Resting bood pressure, measured in a seated position with an automatic shygmomanometer 297493 0
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Timepoint: Baseline, 5 months and 18 months 297493 0
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Secondary Outcome: Staphylococcus aureus nasal carriage by culture of nasal swabs. 297494 0
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Timepoint: Baseline, 6 months, 12 months and 18 months 297494 0
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Secondary Outcome: Dandruff/dry scalp by participant reports. 297495 0
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Timepoint: Baseline and 5 months 297495 0
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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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Gender Both males and females
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Healthy volunteers? 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 type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Describe the 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 (choose all that apply)


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Assignment
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Other design features
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Type of endpoint(s)
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 22/02/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 320
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

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Recruitment outside Australia

Country: New Zealand 1831 0
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State/Province: 1831 0
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Funding Source: Government body 237137 0
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Name: Health Research Council of New Zealand 237137 0
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Address: Level 3, 110 Stanley Street, Auckland 1010 237137 0
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Country: New Zealand 237137 0
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Primary Sponsor 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: University 4628 0
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Name: University of Auckland 4628 0
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Address: P.O. Box 92019, Auckland 1142 4628 0
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Country: New Zealand 4628 0
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Other Collaborator: Hospital 707 0
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Name: Canterbury Health Laboratories 707 0
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Address: P.O. Box 151, Christchurch 8011 707 0
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Country: New Zealand 707 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: 239230 0
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Address: 239230 0
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Country: 239230 0
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Approval Date: 239230 0
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Submitted Date: 30/06/2009 239230 0
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HREC: 239230 0
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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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Principal Investigator
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Contact person for public queries
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Name: David Murdoch
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Address: University of Otago, Christchurch P.O. Box 4345 Christchurch 8140
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Country: New Zealand
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Tel: +64 3 364 0590
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Email: david.murdoch@cdhb.govt.nz
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Contact person for scientific queries
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Name: David Murdoch
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Address: University of Otago, Christchurch P.O. Box 4345 Christchurch 8140
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Country: New Zealand
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Email: david.murdoch@cdhb.govt.nz
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