Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-03 @ 6:48 PM
Study NCT ID:
NCT01158560
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2010-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections
Sponsor:
St. Joseph's Healthcare Hamilton
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: