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

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.

Study Overview

• Status: Completed
• Conditions: Infections; Upper Respiratory Tract Infections; Rhinovirus
• Intervention / Treatment: Dietary supplement: cholecalciferol (vitamin D3); Behavioral: Gargling; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of individuals with self-reported URTI in each of the intervention and control groups	Over the course of 8 weeks spanning September and October

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: McMaster University
• Investigators: Principal Investigator: Marek Smieja, MD, MSc, PhD, FRCPC, St. Joseph's Healthcare, McMaster University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (Estimate): July 8, 2010

Study Record Updates

• Last Update Posted (Estimate): March 5, 2012
• Last Update Submitted That Met QC Criteria: March 2, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: vitamin D; upper respiratory tract infections; rhinovirus infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: McFlu2 10-313