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| Name | Class |
|---|---|
| McMaster University | OTHER |
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The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that
In the current study, we propose investigating the roles of vitamin D supplementation and of regular gargling to prevent URTI/ILI. Vitamin D may be an important factor in respiratory health. Observational studies have associated low serum 25(OH)D levels with more frequent and more severe respiratory infections. However, evidence is lacking that replacement of vitamin D decreases respiratory infections. Four interventional studies of vitamin D supplementation have noted a reduction in respiratory infections, with an estimated 5-25% reduction, but results were not statistically significant.
In Japanese populations, gargling has been found to significantly reduce the incidence of upper respiratory tract infections by approximately 35% (Satomura et al., 2005). This intervention has not been studied in different populations but may be a useful personal practice to reduce URTI.
We propose a 2X2 factorial, randomized, placebo-controlled trial of vitamin D/placebo and gargling/no gargling to study the effects of vitamin D supplementation and gargling on upper respiratory tract infections in McMaster students. This study will be conducted over two years, during September and October of each study year, to capture the natural peak in rhinovirus activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D and gargling | Experimental | Participants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and asked to gargle with tap water twice daily |
|
| Vitamin D and general health advice | Experimental | Participants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and will receive general health advice in place of gargling advice |
|
| Placebo and general health advice | Placebo Comparator | Participants will be given an aesthetically matched placebo capsule to take once weekly and will be given general health advice in place of gargling advice. |
|
| Placebo and gargling | Placebo Comparator | Participants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol (vitamin D3) | Dietary Supplement | oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of individuals with self-reported URTI in each of the intervention and control groups | Over the course of 8 weeks spanning September and October |
| Measure | Description | Time Frame |
|---|---|---|
| The severity of symptoms in each of the intervention and control groups | Daily symptom surveys will be completed for 7 consecutive days follwing the onset of illness. A follow-up survey will be administered at day 14. Surveys will score the severity of symptoms. | Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14 |
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Inclusion Criteria:
Current or part-time student at McMaster University
17 year of age or older
Currently living:
i. In residence or, ii. Off-campus with at least one student housemate
Willing and able to sign an informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marek Smieja, MD, MSc, PhD, FRCPC | St. Joseph's Healthcare, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36715243 | Derived | Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6. | |
| 33215698 | Derived |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract 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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| Gargling | Behavioral | gargling with tap water, twice daily |
|
| Placebo | Dietary Supplement | matched placebo for active vitamin D |
|
| Duration of symptoms in each of the intervention and control groups | Daily symptom surveys will be completed for 7 consecutive days follwing the onset of illness. A follow-up survey will be administered at day 14. | Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14 |
| Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5. |
| 24885201 | Derived | Goodall EC, Granados AC, Luinstra K, Pullenayegum E, Coleman BL, Loeb M, Smieja M. Vitamin D3 and gargling for the prevention of upper respiratory tract infections: a randomized controlled trial. BMC Infect Dis. 2014 May 19;14:273. doi: 10.1186/1471-2334-14-273. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |