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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

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date April 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2017)
  • Objective fever [ Time Frame: 2 weeks after the start of the intervention ]
    Measured fever (≥37.5°C any time during the day) (Yes / No)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold
Official Title  ICMJE The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold: a Randomized Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Common Cold
  • Respiratory Tract Infections
Intervention  ICMJE
  • 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.
  • Device: Placebo lozenges
    Placebo lozenges
Study Arms  ICMJE
  • 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.
    Intervention: Device: Lozenges
  • Placebo Comparator: Placebo lozenges
    The placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste.
    Intervention: Device: Placebo lozenges
Publications * Hemilä H, Haukka J, Alho M, Vahtera J, Kivimäki 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2018)
87
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2017)
200
Actual Study Completion Date  ICMJE September 24, 2018
Actual Primary Completion Date April 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309995
Other Study ID Numbers  ICMJE HelZinki Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Harri Hemilä, MD, PhD, University of Helsinki
Study Sponsor  ICMJE University of Helsinki
Collaborators  ICMJE The University Pharmacy, Helsinki
Investigators  ICMJE
Principal Investigator: Harri Hemilä, MD, PhD University of Helsinki
PRS Account University of Helsinki
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP