Trial Review

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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
Scientific title
Evaluating the impact of zinc supplementation on the incidence of respiratory infections in COPD patients
Secondary ID [1] 312849 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory infections 334984 0
Chronic obstructive pulmonary disease (COPD) 335249 0
Condition category
Condition code
Respiratory 331502 331502 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329395 0
Treatment: Other
Comparator / control treatment
Maltodextrin tablet
Control group
Placebo

Outcomes
Primary outcome [1] 339243 0
Incidence of respiratory infection
Timepoint [1] 339243 0
Baseline, 6 months, 12 months (primary timepoint) post-baseline
Secondary outcome [1] 439212 0
Lung function
Timepoint [1] 439212 0
Baseline and every 6 months over 12 months post-baseline
Secondary outcome [2] 439213 0
Rate of antibiotic use
Timepoint [2] 439213 0
Baseline and every 6 months over 12 months post-baseline
Secondary outcome [3] 439214 0
Inflammation levels
Timepoint [3] 439214 0
Baseline and every 6 months over 12 months post-baseline

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.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered opaque containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317289 0
Government body
Name [1] 317289 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 317289 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319569 0
None
Name [1] 319569 0
Address [1] 319569 0
Country [1] 319569 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316026 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316026 0
Ethics committee country [1] 316026 0
Australia
Date submitted for ethics approval [1] 316026 0
09/09/2024
Approval date [1] 316026 0
Ethics approval number [1] 316026 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136550 0
Dr Patrick Asare
Address 136550 0
University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000.
Country 136550 0
Australia
Phone 136550 0
+61 410346185
Fax 136550 0
Email 136550 0
patrick.asare@adelaide.edu.au
Contact person for public queries
Name 136551 0
Patrick Asare
Address 136551 0
University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000.
Country 136551 0
Australia
Phone 136551 0
+61 410346185
Fax 136551 0
Email 136551 0
patrick.asare@adelaide.edu.au
Contact person for scientific queries
Name 136552 0
Patrick Asare
Address 136552 0
University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000.
Country 136552 0
Australia
Phone 136552 0
+61 410346185
Fax 136552 0
Email 136552 0
patrick.asare@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.