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

St. Joseph's Healthcare Hamilton

Status and phase: Completed; Phase 3

Conditions: Rhinovirus; Upper Respiratory Tract Infections; Infections

Treatments: Dietary Supplement: cholecalciferol (vitamin D3); Behavioral: Gargling; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01158560

McFlu2 10-313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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600 participants in 4 patient groups, including a placebo group

Vitamin D and gargling

Experimental group

Description:

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

Treatment:

Dietary Supplement: cholecalciferol (vitamin D3)

Behavioral: Gargling

Vitamin D and general health advice

Experimental group

Description:

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

Treatment:

Dietary Supplement: cholecalciferol (vitamin D3)

Placebo and general health advice

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Placebo and gargling

Placebo Comparator group

Description:

Participants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily

Treatment:

Behavioral: Gargling

Dietary Supplement: Placebo