Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000054819
Ethics application status
Approved
Date submitted
11/01/2012
Date registered
11/01/2012
Date last updated
18/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Cholecalciferol (Vitamin D) Intervention to Prevent Respiratory Infection Study
Scientific title
A double-blind randomised controlled trial to evaluate the efficacy of 20,000 IU/wk cholecalciferol in reducing respiratory tract infection in a cohort of healthy young adults
Secondary ID [1] 279686 0
Nil
Universal Trial Number (UTN)
U1111-1126-9425
Trial acronym
CIPRIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infection 285511 0
Condition category
Condition code
Infection 285701 285701 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cholecalciferol (20,000 IU oral capsule/week) for 17 weeks.
Intervention code [1] 283976 0
Prevention
Comparator / control treatment
Placebo (microcellulose capsule)
Control group
Placebo

Outcomes
Primary outcome [1] 286229 0
Frequency of validated respiratory tract infections during study period. Acute respiratory tract infections defined by respiratory symptoms reported by daily online survey lasting over a day and verified at exam by study nurse.
Timepoint [1] 286229 0
17 weeks
Secondary outcome [1] 295418 0
the proportion of colonisations with respiratory pathogens that go on to symptomatic verified respiratory tract infections. Colonisation detected by nasal swab sampled quantitiative RT-PCR.
Timepoint [1] 295418 0
17 weeks
Secondary outcome [2] 295419 0
Severity (objective and subjective) of respiratory tract infections during the study. Subjective severity of symptoms reported by Likert scale (0-5) for each symptom. Objective severity by number and duration of symptoms.
Timepoint [2] 295419 0
17 weeks
Secondary outcome [3] 295420 0
Mean duration of respiratory tract infections during study. Duration defined as number of days from participant-reported symptom onset to sympton resolution, as reported in daily online questionnaire.
Timepoint [3] 295420 0
17 weeks
Secondary outcome [4] 295421 0
Frequency of non-respiratory tract infections during study. Non-respiratory tract infections defined by non-respiratory symptoms reported by daily online survey lasting over a day and verified at exam by study nurse.
Timepoint [4] 295421 0
17 weeks
Secondary outcome [5] 295422 0
Concentration of serum 25-hydroxyvitamin D by the end of the study
Timepoint [5] 295422 0
17 weeks

Eligibility
Key inclusion criteria
Students undertaking study at the MS1 building of University of Tasmania Medical Sciences Precinct (17 Liverpool St Hobart TAS) for the full duration between May and September 2012
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Persons who have used tobacco within the 6 months preceding study entry
-Persons who have used any vitamin D (cholecalciferol or ergocalciferol) supplements or calcium supplements within the 3 months preceding study entry and/or persons who refuse to not start taking any such supplement during the study
-Persons using any immunomodulatory medication, diuretic medication, antiepileptic medication, or barbiturates.
-Persons who presently have been diagnosed with any chronic infectious disease (e.g. HIV, tuberculosis), chronic immune deficiency or autoimmune condition, or respiratory condition (e.g. asthma, chronic obstructive pulmonary disease).
-Persons who are hypersensitive to vitamin D.

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)
Eligible subjects will be scheduled for an initial session at which their allocation will be dispensed. Neither the participant nor the investigator dispensing treatment allocation or the nurse evaluating participants for the presence of verified acute respiratory tract infections will be aware of the participant's treatment allocation until after the conclusion of the study. Allocation concealment will be by numbering 32 containers and utilising a blocked randomisation computer program to distribute an equivalent number between intervention and placebo blocked on gender. Only the external monitor will know which numbered containers contain intervention and which contain placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation, blocked on sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
15/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4849 0
7000

Funding & Sponsors
Funding source category [1] 284467 0
Charities/Societies/Foundations
Name [1] 284467 0
Royal Hobart Hospital Research Foundation
Country [1] 284467 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute Tasmania, University of Tasmania
Address
17 Liverpool St
Hobart TAS 7001
Country
Australia
Secondary sponsor category [1] 283392 0
Hospital
Name [1] 283392 0
Royal Hobart Hospital
Address [1] 283392 0
48 Liverpool St
Hobart TAS 7001
Country [1] 283392 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286449 0
Tasmanian Health & Medical Human Research Ethics Committee
Ethics committee address [1] 286449 0
Ethics committee country [1] 286449 0
Australia
Date submitted for ethics approval [1] 286449 0
20/01/2012
Approval date [1] 286449 0
Ethics approval number [1] 286449 0
EC00337

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

Contacts
Principal investigator
Name 33601 0
Address 33601 0
Country 33601 0
Phone 33601 0
Fax 33601 0
Email 33601 0
Contact person for public queries
Name 16848 0
Dr Steve Simpson, Jr.
Address 16848 0
Menzies Research Institute Tasmania
Private bag 23
Hobart TAS 7000
Country 16848 0
Australia
Phone 16848 0
+61 03 6226 4718
Fax 16848 0
+61 03 6226 7704
Email 16848 0
[email protected]
Contact person for scientific queries
Name 7776 0
Dr Steve Simpson, Jr.
Address 7776 0
Menzies Research Institute Tasmania
Private bag 23
Hobart TAS 7000
Country 7776 0
Australia
Phone 7776 0
+61 03 6226 4718
Fax 7776 0
+61 03 6226 7704
Email 7776 0
[email protected]

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
No additional documents have been identified.