NCT01158560

A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Upper Respiratory Tract Infections
• Rhinovirus
• Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol (vitamin D3)	oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks
BEHAVIORAL	Gargling	gargling with tap water, twice daily
DIETARY_SUPPLEMENT	Placebo	matched placebo for active vitamin D

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-07-08
• Last updated: 2012-03-05

Locations

1 site across 1 country: Canada