Common ColdHelZinkiNCT03309995
The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold
A study testing Lozenges in people with Common Cold and Respiratory Tract Infections, run by University of Helsinki at 1 site in Finland.
Trial summary
A randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both participants and investigators blinded. The zinc lozenge that will be used in the study is a commercial product available from the University Pharmacy, Helsinki, Finland. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Respiratory Tract Infections
- What is being tested?
- Lozenges
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2017to 24 Sep 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years, recollecting that they usually have had ≥1 colds per winter.
Who cannot join
- pregnancy or lactation; chronic runny nose or chronic cough.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold: a Randomized Trial
A randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both participants and investigators blinded.
The zinc lozenge that will be used in the study is a commercial product available from the University Pharmacy, Helsinki, Finland. The product is classified as a "medical device" and it is not regulated according to the jurisdiction for medicines.
Read more
Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction in the commercial package for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days. The same instruction will be used in this trial.
The University Pharmacy prepared 200 placebo lozenge packages so that the placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste. 200 packages of zinc lozenges will be used as the active intervention. The packages will contain 30 lozenges (6 lozenges/day × 5 days).
The packages of lozenges will be distributed to the enrolled participants in November 2017. The participants will be instructed to keep the package readily available so that, when they catch the common cold, they will find the package and they can start to take the lozenges according to the instructions.
The participants will be instructed to start taking zinc lozenges as soon as they start to suffer from the first symptoms of the common cold. The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible. The duration of intervention is for the maximum of 5 days. If the symptoms disappear before 5 days, the participant may stop the usage of the lozenges.
There will be no limitations for other treatments that participants wish to use for treating their colds.
Participants will be requested to respond to a web-based symptom questionnaire daily from the first day of the treatment to the recovery from the common cold, or to a maximum of 2 weeks.
- Conditions
- Common Cold, Respiratory Tract Infections
- Being tested
- Lozenges, Placebo lozenges
- Keywords
- Cough, Laryngitis, Pharyngitis, Rhinitis, Zinc Acetate, Zinc Lozenge
- Medical subject headings
- Common Cold, Respiratory Tract Infections, Cough, Laryngitis, Pharyngitis, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LozengesDevice
The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible.
Placebo lozengesDevice
Placebo lozenges
| Study group | Role | What they receive |
|---|---|---|
| Zinc lozenges | Experimental | Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days, as early as possible from the start of the cold symptoms. Receives: Device: Lozenges |
| Placebo lozenges | Placebo comparator | The placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste. Receives: Device: Placebo lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of the common cold (time to recovery)
Data of 12 common cold symptoms will be recorded by patients to web-based system, with scale 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe symptom. The symptom score is calculated as a sum over all the symptoms which means that the maximum of the symptom score scale is 3×12 = 36 points. Recovery from the cold is defined as the day when the symptom score is 0 or 1.
Measured: 2 weeks after the start of the intervention
Secondary outcomes (4)
Objective fever
Measured fever (≥37.5°C any time during the day) (Yes / No)
Measured: 2 weeks after the start of the intervention
Sickness absence
Data will be collected of the absence from work after the start of intervention
Measured: About 1 month after the start of the intervention
Usage of antibiotics and/or asthma medication
Data will be collected of the usage of antibiotics and/or asthma medication after the start of intervention
Measured: About 1 month after the start of the intervention
Complications such as sinusitis, bronchitis, otitis.
Data will be collected of the occurrence of sinusitis, bronchitis, otitis after the start of intervention
Measured: About 1 month after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Dec 2017
- Primary completion24 Apr 2018
- Study completion24 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- The University Pharmacy, Helsinki
- Responsible party
- Principal investigator, Harri Hemilä, MD, PhD, University of Helsinki
- Investigators
- Harri Hemilä, MD, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309995
- Sponsor's protocol ID
- HelZinki Study
- Acronym
- HelZinki
- Status last verified
- Jan 2020
- First submitted
- 10 Oct 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD reported with the trial report (2020)
Publications
Hemila H, Haukka J, Alho M, Vahtera J, Kivimaki M. Zinc acetate lozenges for the treatment of the common cold: a randomised controlled trial. BMJ Open. 2020 Jan 23;10(1):e031662. doi: 10.1136/bmjopen-2019-031662.
PubMed 31980506
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03309995
- Acronym / sponsor ID
- HelZinki / HelZinki Study
- Conditions
- Common Cold, Respiratory Tract Infections
- Keywords
- Cough, Laryngitis, Pharyngitis, Rhinitis, Zinc Acetate, Zinc Lozenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- The University Pharmacy, Helsinki
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- 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.
A randomized parallel-group two arm superiority trial with an allocation ratio 1:1, both participants and investigators blinded.
The zinc lozenge that will be used in the study is a commercial product available from the University Pharmacy, Helsinki, Finland. The product is classified as a "medical device" and it is not regulated according to the jurisdiction for medicines.
Each lozenge contains 13 mg elemental zinc as zinc acetate. The instruction in the commercial package for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days. The same instruction will be used in this trial.
The University Pharmacy prepared 200 placebo lozenge packages so that the placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste. 200 packages of zinc lozenges will be used as the active intervention. The packages will contain 30 lozenges (6 lozenges/day × 5 days).
The packages of lozenges will be distributed to the enrolled participants in November 2017. The participants will be instructed to keep the package readily available so that, when they catch the common cold, they will find the package and they can start to take the lozenges according to the instructions.
The participants will be instructed to start taking zinc lozenges as soon as they start to suffer from the first symptoms of the common cold. The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible. The duration of intervention is for the maximum of 5 days. If the symptoms disappear before 5 days, the participant may stop the usage of the lozenges.
There will be no limitations for other treatments that participants wish to use for treating their colds.
Participants will be requested to respond to a web-based symptom questionnaire daily from the first day of the treatment to the recovery from the common cold, or to a maximum of 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc lozenges | Experimental | Device: LozengesEach lozenge contains 13 mg elemental zinc as zinc acetate. The instruction for common cold patients is to dissolve slowly 6 lozenges per day in their mouth, which totals to 78 mg/day of elemental zinc, at most for 5 days, as early as possible from the start of the cold symptoms. |
| Placebo lozenges | Placebo comparator | Device: Placebo lozengesThe placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18 years, recollecting that they usually have had ≥1 colds per winter.
Key exclusion criteria (1 listed)
- pregnancy or lactation; chronic runny nose or chronic cough.
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 |
|---|---|---|
| LozengesThe participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible. | Device | Zinc lozenges |
| Placebo lozengesPlacebo lozenges | Device | Placebo lozenges |
Primary outcome
The duration of the common cold (time to recovery)
Time frame: 2 weeks after the start of the intervention
Data of 12 common cold symptoms will be recorded by patients to web-based system, with scale 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe symptom. The symptom score is calculated as a sum over all the symptoms which means that the maximum of the symptom score scale is 3×12 = 36 points. Recovery from the cold is defined as the day when the symptom score is 0 or 1.
4 secondary outcomes
Objective fever
Time frame: 2 weeks after the start of the intervention
Sickness absence
Time frame: About 1 month after the start of the intervention
Usage of antibiotics and/or asthma medication
Time frame: About 1 month after the start of the intervention
Complications such as sinusitis, bronchitis, otitis.
Time frame: About 1 month after the start of the intervention
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 Feb 2020.
- Results publication: PubMed 31980506Hemila H, Haukka J, Alho M, Vahtera J, Kivimaki M. Zinc acetate lozenges for the treatment of the common cold: a randomised controlled trial. BMJ Open. 2020 Jan 23;10(1):e031662. doi: 10.1136/bmjopen-2019-031662.
- Report of the trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD reported with the trial report (2020)
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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.
Harri Hemilä, MD, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lozenges in people with Common Cold and Respiratory Tract Infections, run by University of Helsinki at 1 site in Finland.
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 1 inclusion and 1 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 Feb 2020. 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 Finland. 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.
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 duration of the common cold (time to recovery) (time frame: 2 weeks after the start of the intervention). 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 NCT03309995, which also lists 1 linked publication.
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 Feb 2020.