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The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold (HelZinki)

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ClinicalTrials.gov Identifier: NCT03309995
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
The University Pharmacy, Helsinki
Information provided by (Responsible Party):
Harri Hemilä, MD, PhD, University of Helsinki

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Common Cold Respiratory Tract Infections Device: Lozenges Device: Placebo lozenges Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold: a Randomized Trial
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : September 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zinc lozenges
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.
 Device: Lozenges
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 Comparator: Placebo lozenges
The placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste.
 Device: Placebo lozenges
Placebo lozenges


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Objective fever [ Time Frame: 2 weeks after the start of the intervention ]
    Measured fever (≥37.5°C any time during the day) (Yes / No)

  2. Sickness absence [ Time Frame: About 1 month after the start of the intervention ]
    Data will be collected of the absence from work after the start of intervention

  3. Usage of antibiotics and/or asthma medication [ Time Frame: About 1 month after the start of the intervention ]
    Data will be collected of the usage of antibiotics and/or asthma medication after the start of intervention

  4. Complications such as sinusitis, bronchitis, otitis. [ Time Frame: About 1 month after the start of the intervention ]
    Data will be collected of the occurrence of sinusitis, bronchitis, otitis after the start of intervention


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥18 years, recollecting that they usually have had ≥1 colds per winter.

Exclusion Criteria:

  • pregnancy or lactation; chronic runny nose or chronic cough.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309995


Locations
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Finland
City of Helsinki
Helsinki, Finland
Sponsors and Collaborators
University of Helsinki
The University Pharmacy, Helsinki
Investigators
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Principal Investigator: Harri Hemilä, MD, PhD University of Helsinki
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Harri Hemilä, MD, PhD, Senior researcher, docent, University of Helsinki
ClinicalTrials.gov Identifier: NCT03309995    
Other Study ID Numbers: HelZinki Study
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD reported with the trial report (2020)
Time Frame: Upon the publication of trial report indefinitely
Access Criteria: IPD reported with the trial report (2020) is freely available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harri Hemilä, MD, PhD, University of Helsinki:
Cough
Laryngitis
Pharyngitis
 Rhinitis
Zinc Acetate
Zinc Lozenge
Additional relevant MeSH terms:
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Respiratory Tract Infections
Common Cold
Infections
Respiratory Tract Diseases
 Picornaviridae Infections
RNA Virus Infections
Virus Diseases