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

NCT01158560 | Completed Phase 3 DMC

• 1 other identifier: McFlu2 10-313
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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. 1.Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
2. 2.Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.

Conditions

Upper Respiratory Tract Infections; Rhinovirus; Infections

Keywords

upper respiratory tract infections; rhinovirus infections; vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The severity of symptoms in each of the intervention and control groups

  Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14

• Duration of symptoms in each of the intervention and control groups

  Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14

Study Arms (4)

Vitamin D and gargling

EXPERIMENTAL

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); Behavioral: Gargling

Vitamin D and general health advice

EXPERIMENTAL

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)

Placebo and general health advice

PLACEBO COMPARATOR

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

Placebo and gargling

PLACEBO COMPARATOR

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; Dietary Supplement: Placebo

Interventions

cholecalciferol (vitamin D3) DIETARY_SUPPLEMENT

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

Vitamin D and gargling; Vitamin D and general health advice

Gargling BEHAVIORAL

gargling with tap water, twice daily

Placebo and gargling; Vitamin D and gargling

Placebo DIETARY_SUPPLEMENT

matched placebo for active vitamin D

Placebo and gargling; Placebo and general health advice

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or part-time student at McMaster University
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• McMaster University: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (3)

• 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.

  PMID: 36715243 DERIVED

• 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.

  PMID: 33215698 DERIVED

• 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.

  PMID: 24885201 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Marek Smieja, MD, MSc, PhD, FRCPC

  St. Joseph's Healthcare, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 8, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

CA (1)