Skip to main content
OpenTrials
Completed

NCT Number: NCT03309995

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Common Cold Cough Infections Laryngeal Diseases Laryngitis Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Picornaviridae Infections RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Signs and Symptoms Signs and Symptoms, Respiratory Stomatognathic Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Helsinki

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lozenges

Device

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 lozenges

Device

Placebo lozenges

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • The University Pharmacy, Helsinki

Registry information

Official study title

The Effect of Zinc Acetate Lozenges on the Rate of Recovery From the Common Cold: a Randomized Trial

Acronym: HelZinki

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.