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

Primary Purpose

Upper Respiratory Tract Infections, Rhinovirus, Infections

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
cholecalciferol (vitamin D3)
Gargling
Placebo
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Tract Infections focused on measuring upper respiratory tract infections, rhinovirus infections, vitamin D

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Vitamin D and gargling

Vitamin D and general health advice

Placebo and general health advice

Placebo and gargling

Arm Description

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

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

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.

Participants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily

Outcomes

Primary Outcome Measures

The number of individuals with self-reported URTI in each of the intervention and control groups

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2010
Last Updated
March 2, 2012
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01158560
Brief Title
A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, Rhinovirus, Infections
Keywords
upper respiratory tract infections, rhinovirus infections, vitamin D

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D and gargling
Arm Type
Experimental
Arm Description
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
Arm Title
Vitamin D and general health advice
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo and general health advice
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Placebo and gargling
Arm Type
Placebo Comparator
Arm Description
Participants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol (vitamin D3)
Intervention Description
oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Gargling
Intervention Description
gargling with tap water, twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
matched placebo for active vitamin D
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The severity of symptoms in each of the intervention and control groups
Description
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.
Time Frame
Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14
Title
Duration of symptoms in each of the intervention and control groups
Description
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.
Time Frame
Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Smieja, MD, MSc, PhD, FRCPC
Organizational Affiliation
St. Joseph's Healthcare, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33215698
Citation
Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
Results Reference
derived
PubMed Identifier
24885201
Citation
Goodall EC, Granados AC, Luinstra K, Pullenayegum E, Coleman BL, Loeb M, Smieja M. Vitamin D3 and gargling for the prevention of upper respiratory tract infections: a randomized controlled trial. BMC Infect Dis. 2014 May 19;14:273. doi: 10.1186/1471-2334-14-273.
Results Reference
derived

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

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