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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Common Cold
• Intervention / Treatment: Device: Lozenges; Device: Placebo lozenges

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • City of Helsinki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of the common cold (time to recovery)	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.	2 weeks after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective fever	Measured fever (≥37.5°C any time during the day) (Yes / No)	2 weeks after the start of the intervention
Sickness absence	Data will be collected of the absence from work after the start of intervention	About 1 month after the start of the intervention
Usage of antibiotics and/or asthma medication	Data will be collected of the usage of antibiotics and/or asthma medication after the start of intervention	About 1 month after the start of the intervention
Complications such as sinusitis, bronchitis, otitis.	Data will be collected of the occurrence of sinusitis, bronchitis, otitis after the start of intervention	About 1 month after the start of the intervention

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: The University Pharmacy, Helsinki
• Investigators: Principal Investigator: Harri Hemilä, MD, PhD, University of Helsinki

Publications and helpful links

General Publications

• Hemila H, Haukka J, Alho M, Vahtera J, Kivimaki 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.

Helpful Links

• Report of the trial

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): April 24, 2018
• Study Completion (ACTUAL): September 24, 2018

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (ACTUAL): October 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Cough; Rhinitis; Pharyngitis; Laryngitis; Zinc Acetate; Zinc Lozenge
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Picornaviridae Infections; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: HelZinki Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD reported with the trial report (2020)
• IPD Sharing Time Frame: Upon the publication of trial report indefinitely
• IPD Sharing Access Criteria: IPD reported with the trial report (2020) is freely available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No