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

• ClinicalTrials.gov Identifier: NCT01158560
• Recruitment Status: Completed
• First Posted: July 8, 2010
• Last Update Posted: March 5, 2012
• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborator: McMaster University
• Information provided by (Responsible Party): St. Joseph's Healthcare Hamilton

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

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 or disease	Intervention/treatment	Phase
Upper Respiratory Tract Infections; Rhinovirus; Infections	Dietary Supplement: cholecalciferol (vitamin D3); Behavioral: Gargling; Dietary Supplement: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: September 2010
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: St. Joseph's Healthcare Hamilton
• ClinicalTrials.gov Identifier: NCT01158560
• Other Study ID Numbers: McFlu2 10-313
• First Posted: July 8, 2010
• Last Update Posted: March 5, 2012
• Last Verified: March 2012

Keywords provided by St. Joseph's Healthcare Hamilton:

upper respiratory tract infections; rhinovirus infections; vitamin D

Additional relevant MeSH terms:

Infections; Communicable Diseases; Respiratory Tract Infections; Disease Attributes; Pathologic Processes; Respiratory Tract Diseases; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents