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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01158560
Enrollment
600
Registered
2010-07-08
Start date
2010-09-30
Completion date
2011-10-31
Last updated
2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Respiratory Tract Infections, Rhinovirus, Infections

Keywords

upper respiratory tract infections, rhinovirus infections, vitamin D

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.

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.

Interventions

oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks

BEHAVIORALGargling

gargling with tap water, twice daily

DIETARY_SUPPLEMENTPlacebo

matched placebo for active vitamin D

Sponsors

McMaster University
CollaboratorOTHER
St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
The number of individuals with self-reported URTI in each of the intervention and control groupsOver the course of 8 weeks spanning September and October

Secondary

MeasureTime frameDescription
The severity of symptoms in each of the intervention and control groupsSymptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14Daily 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.
Duration of symptoms in each of the intervention and control groupsSymptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14Daily symptom surveys will be completed for 7 consecutive days follwing the onset of illness. A follow-up survey will be administered at day 14.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026