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

NCT03309995 | Completed

• 1 other identifier: HelZinki Study
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold; Respiratory Tract Infections

Keywords

Cough; Laryngitis; Pharyngitis; Rhinitis; Zinc Acetate; Zinc Lozenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective fever

  2 weeks after the start of the intervention

• Sickness absence

  About 1 month after the start of the intervention

• Usage of antibiotics and/or asthma medication

  About 1 month after the start of the intervention

• Complications such as sinusitis, bronchitis, otitis.

  About 1 month after the start of the intervention

Study Arms (2)

Zinc lozenges

EXPERIMENTAL

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

Placebo lozenges

PLACEBO COMPARATOR

The placebo lozenges contain sucrose octaacetate, and they are similar with the zinc lozenges in visual appearance and in taste.

Device: Placebo lozenges

Interventions

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.

Zinc lozenges

Placebo lozenges DEVICE

Placebo lozenges

Placebo lozenges

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years, recollecting that they usually have had ≥1 colds per winter.

You may not qualify if:

• pregnancy or lactation; chronic runny nose or chronic cough.

Sponsors & Collaborators

• University of Helsinki: lead
• The University Pharmacy, Helsinki: collaborator

Study Sites (1)

City of Helsinki

Helsinki, Finland

Location

Related Publications (1)

• 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.

  PMID: 31980506 RESULT

Related Links

• Report of the trial

MeSH Terms

Conditions

Common Cold; Respiratory Tract Infections; Cough; Laryngitis; Pharyngitis; Rhinitis

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Nose Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Harri Hemilä, MD, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, docent

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 16, 2017
• Study Start: December 1, 2017
• Primary Completion: April 24, 2018
• Study Completion: September 24, 2018
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon the publication of trial report indefinitely
• Access Criteria: IPD reported with the trial report (2020) is freely available

Locations

FI (1)