McMaster University
Hamilton, Ontario, Canada
NCT Number: NCT01158560
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
1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students 2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.
Looking for future studies?
Notify Me17 year and older
All sexes
Interventional
Phase 3
Hamilton, Ontario, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. In residence or, ii. Off-campus with at least one student housemate
Exclusion criteria
oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks
gargling with tap water, twice daily
matched placebo for active vitamin D
Time frame: Over the course of 8 weeks spanning September and October
Time frame: Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14
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.
Time frame: Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14
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.
St. Joseph's Healthcare Hamilton
Other
McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06149494
COPD, COPD Exacerbation Acute
London, United Kingdom
View Trial DetailsNCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT01215682
Infections, Respiratory Tract Diseases
Haifa, Israel
View Trial DetailsNCT04155892
Infections, Respiratory Tract Diseases
Winston-Salem, North Carolina, United States
View Trial Details