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

Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158560
• Other study ID #: McFlu2 10-313
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2010
• Last updated: March 2, 2012
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections
• Respiratory Tract Infections
• Rhinovirus
• Upper Respiratory Tract Infections

Intervention

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

Dietary Supplement:
• Placebo
matched placebo for active vitamin D

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No