Cholecalciferol Intervention to Prevent Respiratory Infections Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Among persons with detected viral colonisations of the nasopharynx, treated persons will have a lower frequency of symptomatic respiratory tract infection resultant than controls. Treated group will have significantly less severe symptomatic RTIs than controls. 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.

Official Title
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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

Conditions
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Respiratory Tract Infection, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>20,000 IU cholecalciferol capsule | Dietary Supplement: Cholecalciferol<br>* 20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.<br>|
| Placebo Comparator: Placebo<br>Microcellulose capsule | Dietary Supplement: Placebo<br>* Microcellulose capsule identical in appearance to treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Cholecalciferol, Respiratory tract infection