Upper Respiratory Tract InfectionsPhase 3NCT01158560
A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections
A Phase 3 study testing cholecalciferol (vitamin D3) and Gargling in people with Upper Respiratory Tract Infections and Rhinovirus, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, Rhinovirus, Infections
- What is being tested?
- cholecalciferol (vitamin D3) and Gargling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Current or part-time student at McMaster University
- 17 year of age or older
- Currently living:
- In residence or, ii. Off-campus with at least one student housemate
- Willing and able to sign an informed consent
Who cannot join
- 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
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- Malabsorption syndromes
- Diagnosis of sarcoidosis
- Currently pregnant or planning a pregnancy
- Inability to swallow capsules
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
- Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.
Read the 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
- Being tested
- cholecalciferol (vitamin D3), Gargling, Placebo
- Keywords
- upper respiratory tract infections, rhinovirus infections, vitamin D
- Medical subject headings
- Respiratory Tract Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferol (vitamin D3)Dietary supplement
oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks
GarglingBehavioural
gargling with tap water, twice daily
PlaceboDietary supplement
matched placebo for active vitamin D
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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 Receives: Behavioral: Gargling; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of individuals with self-reported URTI in each of the intervention and control groups
Measured: 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
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.
Measured: 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
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.
Measured: Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Marek Smieja, MD, MSc, PhD, FRCPC, Principal investigator, St. Joseph's Healthcare, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158560
- Sponsor's protocol ID
- McFlu2 10-313
- Status last verified
- Mar 2012
- First submitted
- 6 Jul 2010
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36715243Jefferson 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.
PubMed 33215698Goodall 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.
PubMed 24885201
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01158560
- Acronym / sponsor ID
- McFlu2 10-313
- Conditions
- Upper Respiratory Tract Infections, Rhinovirus, Infections
- Keywords
- upper respiratory tract infections, rhinovirus infections, vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and gargling | Experimental | Dietary Supplement: cholecalciferol (vitamin D3), Behavioral: GarglingParticipants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and asked to gargle with tap water twice daily |
| Vitamin D and general health advice | Experimental | Dietary Supplement: cholecalciferol (vitamin D3)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 |
| Placebo and general health advice | Placebo comparator | Dietary Supplement: PlaceboParticipants will be given an aesthetically matched placebo capsule to take once weekly and will be given general health advice in place of gargling advice. |
| Placebo and gargling | Placebo comparator | Behavioral: Gargling, Dietary Supplement: PlaceboParticipants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Current or part-time student at McMaster University
- 17 year of age or older
- Currently living:
- Willing and able to sign an informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferol (vitamin D3)oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks | Dietary supplement | Vitamin D and gargling, Vitamin D and general health advice |
| Garglinggargling with tap water, twice daily | Behavioural | Placebo and gargling, Vitamin D and gargling |
| Placebomatched placebo for active vitamin D | Dietary supplement | Placebo and gargling, Placebo and general health advice |
Primary outcome
The number of individuals with self-reported URTI in each of the intervention and control groups
Time frame: Over the course of 8 weeks spanning September and October
2 secondary outcomes
The severity of symptoms in each of the intervention and control groups
Time frame: 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
Time frame: Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- Derived from this study: PubMed 36715243Jefferson 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.
- Derived from this study: PubMed 33215698Jefferson 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.
- Derived from this study: PubMed 24885201Goodall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Smieja, MD, MSc, PhD, FRCPC principal investigator
St. Joseph's Healthcare, McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cholecalciferol (vitamin D3) and Gargling in people with Upper Respiratory Tract Infections and Rhinovirus, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of individuals with self-reported URTI in each of the intervention and control groups (time frame: Over the course of 8 weeks spanning September and October). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158560, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.