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Completed

NCT Number: NCT01158560

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

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster University

Hamilton, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol (vitamin D3)

Dietary Supplement

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

Gargling

Behavioral

gargling with tap water, twice daily

Placebo

Dietary Supplement

matched placebo for active vitamin D

Primary outcomes

  1. 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

  1. The severity of symptoms in each of the intervention and control groups

    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.

  2. Duration of symptoms in each of the intervention and control groups

    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.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • McMaster University

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2010
Registry last updated
Mar 5, 2012

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.

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