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

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01158560
First received: July 6, 2010
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Upper Respiratory Tract Infections
Rhinovirus
Infections
 Dietary Supplement: cholecalciferol (vitamin D3)
Behavioral: Gargling
Dietary Supplement: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 600
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D and gargling
Participants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and asked to gargle with tap water twice daily
 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
Experimental: Vitamin D and general health advice
Participants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and will receive general health advice in place of gargling advice
 Dietary Supplement: cholecalciferol (vitamin D3)
oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks
Placebo Comparator: Placebo and general health advice
Participants will be given an aesthetically matched placebo capsule to take once weekly and will be given general health advice in place of gargling advice.
 Dietary Supplement: Placebo
matched placebo for active vitamin D
Placebo Comparator: Placebo and gargling
Participants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily
 Behavioral: Gargling
gargling with tap water, twice daily
Dietary Supplement: Placebo
matched placebo for active vitamin D

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158560

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Investigators
Principal Investigator: Marek Smieja, MD, MSc, PhD, FRCPC St. Joseph's Healthcare, McMaster University
  More Information

No publications provided

Responsible Party: St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01158560     History of Changes
Other Study ID Numbers: McFlu2 10-313
Study First Received: July 6, 2010
Last Updated: March 2, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Joseph's Healthcare Hamilton:
upper respiratory tract infections
rhinovirus infections
vitamin D

Additional relevant MeSH terms:
Respiratory Tract Infections
Common Cold
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Cholecalciferol
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013