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

NCT ID: NCT01158560

Last Updated: 2012-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-10-31

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.

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.

Conditions

Upper Respiratory Tract Infections; Rhinovirus; Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

cholecalciferol (vitamin D3)

Intervention Type: DIETARY_SUPPLEMENT

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

Gargling

Intervention Type: BEHAVIORAL

gargling with tap water, twice daily

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

Group Type: EXPERIMENTAL

cholecalciferol (vitamin D3)

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

matched placebo for active vitamin D

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

Group Type: PLACEBO_COMPARATOR

Gargling

Intervention Type: BEHAVIORAL

gargling with tap water, twice daily

Placebo

Intervention Type: DIETARY_SUPPLEMENT

matched placebo for active vitamin D

Interventions

cholecalciferol (vitamin D3)

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

Intervention Type: DIETARY_SUPPLEMENT

Gargling

gargling with tap water, twice daily

Intervention Type: BEHAVIORAL

Placebo

matched placebo for active vitamin D

Intervention Type: DIETARY_SUPPLEMENT

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

• 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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marek Smieja, MD, MSc, PhD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare, McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.

Reference Type: DERIVED

PMID: 36715243 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33215698 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24885201 (View on PubMed)

Other Identifiers

McFlu2 10-313

Identifier Type: -

Identifier Source: org_study_id