Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001317583
Ethics application status
Approved
Date submitted
31/10/2024
Date registered
31/10/2024
Date last updated
5/11/2024
Date data sharing statement initially provided
31/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Test ANZCTR-258/259
Scientific title
Test ANZCTR-258/259
Secondary ID [1] 313280 0
2132145352634635
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 335604 0
Condition category
Condition code
Blood 332170 332170 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
test
Intervention code [1] 329854 0
Not applicable
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 339762 0
test
Timepoint [1] 339762 0
test
Secondary outcome [1] 441159 0
test
Timepoint [1] 441159 0
test

Eligibility
Key inclusion criteria
test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
test

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2024
Date of last participant enrolment
Anticipated
Actual
16/10/2024
Date of last data collection
Anticipated
28/11/2024
Actual
Sample size
Target
1000
Accrual to date
Final
2000
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27290 0
The Hills Clinic - Kellyville
Recruitment postcode(s) [1] 43377 0
2155 - Kellyville

Funding & Sponsors
Funding source category [1] 317728 0
Hospital
Name [1] 317728 0
test
Country [1] 317728 0
Australia
Primary sponsor type
Government body
Name
test
Address
Country
Australia
Secondary sponsor category [1] 320044 0
None
Name [1] 320044 0
Address [1] 320044 0
Country [1] 320044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316418 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 316418 0
Ethics committee country [1] 316418 0
Australia
Date submitted for ethics approval [1] 316418 0
31/10/2024
Approval date [1] 316418 0
31/10/2024
Ethics approval number [1] 316418 0
Ethics committee name [2] 316419 0
Anglicare Victoria Research Ethics Committee
Ethics committee address [2] 316419 0
Ethics committee country [2] 316419 0
Australia
Date submitted for ethics approval [2] 316419 0
01/11/2024
Approval date [2] 316419 0
Ethics approval number [2] 316419 0

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

Contacts
Principal investigator
Name 137826 0
Mr Nathan Leung
Address 137826 0
test
Country 137826 0
Australia
Phone 137826 0
+61 412345678
Fax 137826 0
Email 137826 0
[email protected]
Contact person for public queries
Name 137827 0
Nathan Leung
Address 137827 0
test
Country 137827 0
Australia
Phone 137827 0
+61 412345678
Fax 137827 0
Email 137827 0
[email protected]
Contact person for scientific queries
Name 137828 0
Nathan Leung
Address 137828 0
test
Country 137828 0
Australia
Phone 137828 0
+61 412345678
Fax 137828 0
Email 137828 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
test


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.