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Trial registered on ANZCTR
Registration number
ACTRN12624001206516p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of Zinc Supplementation in Respiratory Infections in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Randomised Controlled Trial
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Scientific title
Evaluating the impact of zinc supplementation on the incidence of respiratory infections in COPD patients
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Secondary ID [1]
312849
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory infections
334984
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Chronic obstructive pulmonary disease (COPD)
335249
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Condition category
Condition code
Respiratory
331502
331502
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Zinc gluconate, 30 mg, will be administered as a daily oral tablet for 12 months. To monitor adherence, participants will receive a bottle each month, and the remaining tablets will be counted at each visit to assess their compliance with the treatment regimen.
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Intervention code [1]
329395
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Treatment: Other
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Comparator / control treatment
Maltodextrin tablet
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Control group
Placebo
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Outcomes
Primary outcome [1]
339243
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Incidence of respiratory infection
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Assessment method [1]
339243
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Physician review/clinical evaluation and microbiological test (if symptomatic, Respiratory Viral PCR and Sputum culture will be performed (induced Sputum will not be performed)
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Timepoint [1]
339243
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Baseline, 6 months, 12 months (primary timepoint) post-baseline
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Secondary outcome [1]
439212
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Lung function
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Assessment method [1]
439212
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Lung function assessment using spirometry by measuring the ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) post-bronchodilator.
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Timepoint [1]
439212
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Baseline and every 6 months over 12 months post-baseline
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Secondary outcome [2]
439213
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Rate of antibiotic use
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Assessment method [2]
439213
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Physician review and medical history (review of patient electronic medical records)
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Timepoint [2]
439213
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Baseline and every 6 months over 12 months post-baseline
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Secondary outcome [3]
439214
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Inflammation levels
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Assessment method [3]
439214
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Participants will provide peripheral venous blood samples for measurement of C-reactive protein levels
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Timepoint [3]
439214
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Baseline and every 6 months over 12 months post-baseline
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Eligibility
Key inclusion criteria
COPD patients who are over 45 years of age and have a past history of at least 2 exacerbations per year for the last 2 years with no respiratory infection for 6 weeks prior.
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Minimum age
45
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with other respiratory conditions, such as asthma, bronchiectasis, pulmonary fibrosis, or lung cancer and Patients with concomitant diseases where it is not in the patient’s medical interest to receive zinc supplements.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered opaque containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/11/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
58
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
317289
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Government body
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Name [1]
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Department of Health and Aged Care - Medical Research Future Fund (MRFF)
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Address [1]
317289
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Country [1]
317289
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319569
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Address [1]
319569
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Country [1]
319569
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316026
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
316026
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
316026
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Australia
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Date submitted for ethics approval [1]
316026
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09/09/2024
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Approval date [1]
316026
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Ethics approval number [1]
316026
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Summary
Brief summary
COPD is an incurable disease with high morbidity and mortality rates, due to hospitalisations from the condition and antibiotic-resistant respiratory infections. Zinc deficiency could increase the risk of recurrent airway infections. Incorporating zinc therapy into COPD treatment could be a significant breakthrough, particularly in light of our previous findings of low zinc levels in the airways of COPD patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
136550
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Dr Patrick Asare
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Address
136550
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University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000.
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Country
136550
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Australia
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Phone
136550
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+61 410346185
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Fax
136550
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Query!
Email
136550
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[email protected]
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Contact person for public queries
Name
136551
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Patrick Asare
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Address
136551
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University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000.
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Country
136551
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Australia
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Phone
136551
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+61 410346185
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Fax
136551
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Email
136551
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[email protected]
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Contact person for scientific queries
Name
136552
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Patrick Asare
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Address
136552
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University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000.
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Country
136552
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Australia
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Phone
136552
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+61 410346185
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Fax
136552
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Email
136552
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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