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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- The number of individuals with self-reported URTI in each of the intervention and control groups
Study Overview
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
- Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Students who do not meet the inclusion criteria
- •Currently living at home with parents
- •History or diagnosis of hypercalcemia
- •Diagnosis of parathyroid disorder (hyper or hypo)
- •Diagnosis of chronic kidney disease
- •Use of anticonvulsants
- •Malabsorption syndromes
- •Diagnosis of sarcoidosis
- •Currently pregnant or planning a pregnancy
- •Inability to swallow capsules
Outcomes
Primary Outcomes
The number of individuals with self-reported URTI in each of the intervention and control groups
Time Frame: Over the course of 8 weeks spanning September and October
Secondary Outcomes
- The severity of symptoms in each of the intervention and control groups(Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14)
- Duration of symptoms in each of the intervention and control groups(Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14)