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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01549938
Other study ID # CIPRIS
Secondary ID ACTRN12612000054
Status Completed
Phase Phase 2
First received March 7, 2012
Last updated October 17, 2012
Start date May 2012

Study information

Verified date October 2012
Source Menzies Institute for Medical Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The hypotheses of the full study are:

Primary The group treated with vitamin D3 will have a significantly lower frequency of symptomatic respiratory tract infections than controls.

Secondary

1. Among persons with detected viral colonisations of the nasopharynx, treated persons will have a lower frequency of symptomatic respiratory tract infection resultant than controls.

2. Treated group will have significantly less severe symptomatic RTIs than controls.

3. Treated group will have significantly shorter symptomatic RTI durations than controls.

For the pilot, a cohort of 32 healthy young adults satisfying inclusion criteria will be randomised to cholecalciferol supplement or identical placebo and evaluated daily for the occurrence of RTI symptoms and evaluated weekly for the presence of respiratory colonisation by relevant pathogens using nasopharyngeal swab and polymerase chain reaction using selected pathogen-specific primers. This pilot will demonstrate the logistic feasibility of the proposed study design and provide preliminary data which will inform a larger study to be undertaken next year.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

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


Intervention

Dietary Supplement:
Cholecalciferol
20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
Placebo
Microcellulose capsule identical in appearance to treatment

Locations

Country Name City State
Australia Menzies Research Institute Tasmania Hobart Tasmania

Sponsors (2)

Lead Sponsor Collaborator
Menzies Institute for Medical Research Royal Hobart Hospital Research Foundation (funding source)

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of validated respiratory tract infections during study period 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. 17 weeks
Secondary Proportion of colonisations leading to symptomatic respiratory tract infections Proportion of colonisations with respiratory pathogens that go on to symptomatic verified respiratory tract infections. Colonisation detected by nasal swab sampled quantitiative RT-PCR. 17 weeks
Secondary Severity of respiratory tract infections during study 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. 17 weeks
Secondary Mean duration of respiratory tract infections during study 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. 17 weeks
Secondary Frequency of non-respiratory tract infections during study 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. 17 weeks
Secondary Concentration of serum 25-hydroxyvitamin D by the end of the study Concentration of serum 25-hydroxyvitamin D by the end of the study 17 weeks
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