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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01549938




Registration number
NCT01549938
Ethics application status
Date submitted
7/03/2012
Date registered
9/03/2012
Date last updated
19/10/2012

Titles & IDs
Public title
Cholecalciferol Intervention to Prevent Respiratory Infections Study
Scientific title
Cholecalciferol Intervention to Prevent Respiratory Infections Study: 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] 0 0
ACTRN12612000054819
Secondary ID [2] 0 0
CIPRIS
Universal Trial Number (UTN)
Trial acronym
CIPRIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infection 0 0
Vitamin D Deficiency 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Cholecalciferol
Treatment: Other - Placebo

Active comparator: Treatment - 20,000 IU cholecalciferol capsule

Placebo comparator: Placebo - Microcellulose capsule


Treatment: Other: Cholecalciferol
20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.

Treatment: Other: Placebo
Microcellulose capsule identical in appearance to treatment
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of validated respiratory tract infections during study period
Timepoint [1] 0 0
17 weeks
Secondary outcome [1] 0 0
Proportion of colonisations leading to symptomatic respiratory tract infections
Timepoint [1] 0 0
17 weeks
Secondary outcome [2] 0 0
Severity of respiratory tract infections during study
Timepoint [2] 0 0
17 weeks
Secondary outcome [3] 0 0
Mean duration of respiratory tract infections during study
Timepoint [3] 0 0
17 weeks
Secondary outcome [4] 0 0
Frequency of non-respiratory tract infections during study
Timepoint [4] 0 0
17 weeks
Secondary outcome [5] 0 0
Concentration of serum 25-hydroxyvitamin D by the end of the study
Timepoint [5] 0 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Menzies Research Institute Tasmania - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies Institute for Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Hobart Hospital Research Foundation (funding source)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a feasibility double-blind randomised controlled trial in 32 participants. It evaluates the feasibility of a full trial which will examine the efficacy of weekly supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent frequency and severity of objectively-verified symptomatic acute respiratory tract infection, overall and as a proportion of detected colonisations of the upper respiratory tract by 9 of the most common aetiologic viral pathogens.
Trial website
https://clinicaltrials.gov/study/NCT01549938
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steve Simpson, Jr., PhD, MPH
Address 0 0
Menzies Institute for Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01549938