Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001171505p
Ethics application status
Not yet submitted
Date submitted
23/08/2024
Date registered
25/09/2024
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of zinc supplementation as an adjunct therapy in managing idiopathic pulmonary fibrosis
Scientific title
Evaluating the effect of zinc supplementation on lung function in idiopathic pulmonary fibrosis: RCT
Secondary ID [1] 312808 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 334875 0
Condition category
Condition code
Respiratory 331429 331429 0 0
Other respiratory disorders / diseases

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. Adherence will be monitored through tablet returns, where participants will be given a bottle each month, and the remaining pills will be counted at each visit to assess compliance with the treatment regimen.
Intervention code [1] 329346 0
Treatment: Drugs
Comparator / control treatment
Maltodextrin tablet
Control group
Placebo

Outcomes
Primary outcome [1] 339183 0
Lung function
Timepoint [1] 339183 0
FVC will be measured at baseline, 6 months, and 12 months (primary timepoint) post-baseline
Secondary outcome [1] 438972 0
Pulmonary hypertension
Timepoint [1] 438972 0
Baseline and every 6 months over 12 months post-baseline
Secondary outcome [2] 438973 0
Number of acute exacerbations
Timepoint [2] 438973 0
Baseline and every 3 months over 12 months post-baseline
Secondary outcome [3] 439201 0
Number of acute exacerbations days
Timepoint [3] 439201 0
Baseline and every 3 months over 12 months post-baseline

Eligibility
Key inclusion criteria
Patients 40 years of age or older who have received a diagnosis of IPF according to 2022 international guidelines and confirmed by a multidisciplinary team.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
IPF patients with severe co-existing medical conditions as determined by the investigators such as but not limited to advanced cardiovascular diseases, uncontrolled diabetes, or malignancies.

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 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317242 0
Self funded/Unfunded
Name [1] 317242 0
Country [1] 317242 0
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319523 0
None
Name [1] 319523 0
Address [1] 319523 0
Country [1] 319523 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315980 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315980 0
Ethics committee country [1] 315980 0
Australia
Date submitted for ethics approval [1] 315980 0
03/03/2025
Approval date [1] 315980 0
Ethics approval number [1] 315980 0

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

Contacts
Principal investigator
Name 136414 0
Dr Patrick Asare
Address 136414 0
University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000.
Country 136414 0
Australia
Phone 136414 0
+61 410346185
Fax 136414 0
Email 136414 0
[email protected]
Contact person for public queries
Name 136415 0
Patrick Asare
Address 136415 0
University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000
Country 136415 0
Australia
Phone 136415 0
+61 410346185
Fax 136415 0
Email 136415 0
[email protected]
Contact person for scientific queries
Name 136416 0
Patrick Asare
Address 136416 0
University of Adelaide Ahms Building level 7, North Terrace-Adelaide, South Australia 5000
Country 136416 0
Australia
Phone 136416 0
+61 410346185
Fax 136416 0
Email 136416 0
[email protected]

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.