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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12612000054819 | Registry Identifier | Australia and New Zealand Clinical Trials Registry | |
| U1111-1126-9425 | Registry Identifier | World Health Organisation Universal Trial Number |
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| Name | Class |
|---|---|
| Royal Hobart Hospital Research Foundation (funding source) | UNKNOWN |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 20,000 IU cholecalciferol capsule |
|
| Placebo | Placebo Comparator | Microcellulose capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | 20,000 IU cholecalciferol capsule, given once weekly for 16 weeks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Simpson, Jr., PhD, MPH | Menzies Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menzies Research Institute Tasmania | Hobart | Tasmania | 7000 | Australia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2015 | |
| Reset | Oct 19, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2015 | Oct 19, 2015 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Dietary Supplement | Microcellulose capsule identical in appearance to treatment |
|
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 |
| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |