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

This study is not yet open for participant recruitment.
Verified October 2017 by Harri Hemilä, MD, PhD, Helsinki University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03309995
First Posted: October 16, 2017
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The University Pharmacy, Helsinki
Information provided by (Responsible Party):
Harri Hemilä, MD, PhD, Helsinki University
  Purpose

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 Intervention
Common Cold Respiratory Tract Infections Device: Lozenges Device: Placebo lozenges

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Harri Hemilä, MD, PhD, Helsinki University:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 200
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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


Contacts
Contact: Harri Hemilä, MD, PhD +358 41 532 9987 harri.hemila@helsinki.fi

Sponsors and Collaborators
Helsinki University
The University Pharmacy, Helsinki
Investigators
Principal Investigator: Harri Hemilä, MD, PhD Helsinki University
  More Information

Responsible Party: Harri Hemilä, MD, PhD, Senior researcher, docent, Helsinki University
ClinicalTrials.gov Identifier: NCT03309995     History of Changes
Other Study ID Numbers: HelZinki Study
First Submitted: October 10, 2017
First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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, Helsinki University:
Cough
Laryngitis
Pharyngitis
Rhinitis
Zinc Acetate
Zinc Lozenge

Additional relevant MeSH terms:
Respiratory Tract Infections
Common Cold
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs