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

Sponsor

University of Helsinki (Other)

Overall Status

Completed

CT.gov ID

NCT03309995

Collaborator

The University Pharmacy, Helsinki (Other)

Enrollment

Location

Arms

9.8

Actual Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Dec 1, 2017

Actual Primary Completion Date :

Apr 24, 2018

Actual Study Completion Date :

Sep 24, 2018

Arms and Interventions

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

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

Primary Outcome Measures

The duration of the common cold (time to recovery) [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 [2 weeks after the start of the intervention]
Measured fever (≥37.5°C any time during the day) (Yes / No)
Sickness absence [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 [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. [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