Clinical trial NCT01158560: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Respiratory Tract Infections
Rhinovirus
Infections
Keywords: upper respiratory tract infections
rhinovirus infections
vitamin D
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2010-07-08
Enrollment: 600
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The number of individuals with self-reported URTI in each of the intervention and control groups
timeFrame: Over the course of 8 weeks spanning September and October
Secondary outcomes:
measure: The severity of symptoms in each of the intervention and control groups
timeFrame: Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14
measure: Duration of symptoms in each of the intervention and control groups
timeFrame: Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare, McMaster University
name: Marek Smieja, MD, MSc, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.