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Trial registered on ANZCTR


Registration number
ACTRN12618000032257
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
12/01/2018
Date last updated
25/09/2019
Date data sharing statement initially provided
25/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the validity of urinary kryptopyrrole (UKP) testing - quantifying UKP levels in a healthy adult population compared to people diagnosed with anxiety.
Scientific title
Evaluating the validity of urinary kryptopyrrole (UKP) testing - quantifying UKP levels in a healthy adult population compared to people diagnosed with anxiety.
Secondary ID [1] 293350 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pyrrole disorder / pyroluria 305456 0
Condition category
Condition code
Other 304725 304725 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Mental Health 304940 304940 0 0
Anxiety
Mental Health 304941 304941 0 0
Depression
Blood 304944 304944 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This a 4 arm study seeking to validate an in-vitro diagnostic medical device. It requires retrospective observational data from clinicians in the form of a survey, prospective data from healthy adults and adults with a specific condition through concurrent clinical trial, and prospective case report data from clinicians using urinary kryptopyrrole testing which will also be collected concurrently. The first arm (a survey) guides disease selection for arm 3 (observational study). The results of arm 2, 3 and 4, once completed, will be correlated to see any difference between healthy adults and those diagnosed with different diseases.

Arm 2: An observational study of healthy adults. Participants will provide a urine sample on which urinary kryptopyrrole analysis will be performed at baseline, week 1 and week 2 (3 urine samples). Participants will also fill out a questionnaire (the Depression Anxiety Stress Scales 21 (DASS-21)), which will be used for correlation with the urine analysis.

Arm 3: An observational study of people diagnosed with anxiety. Participants will provide a urine sample on which urinary kryptopyrrole analysis will be performed at baseline, week 1 and week 2 (3 urine samples). Participants will also fill out two questionnaires (the Depression Anxiety Stress Scales 21 (DASS-21)) and the GAD-7, which will be both compared to each other, and used for correlation with the urine analysis.

Arm 4: An observational case-control study where clinicians will recruit their patients into this study for baseline and follow-up visits. Clinical practice will commence as normal (including urinary kryptopyrrole [UKP]sampling), but the DASS-21 questionnaire will be added. Case management data will be collected by the research team and analysed for signficance compared to the UKP level, plus correlation between UKP level, disease outcome, and DASS-21 scores.
Intervention code [1] 299607 0
Early Detection / Screening
Intervention code [2] 299608 0
Diagnosis / Prognosis
Comparator / control treatment
Arm 2 (healthy participants) acts as the control for arm 3 and 4.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303936 0
Urinary kryptopyrrole levels.
Timepoint [1] 303936 0
Baseline, 1 week and and 2 weeks.
Secondary outcome [1] 340508 0
Depression Anxiety Stress Scales 21 (DASS-21) questionnaire.
Timepoint [1] 340508 0
Baseline, 1 week and 2 weeks after commencement.
Secondary outcome [2] 344625 0
Generalized Anxiety Disorder 7-item (GAD-7)
Timepoint [2] 344625 0
Baseline, week 1 and week 2.

Eligibility
Key inclusion criteria
Arm 2
* Healthy adults aged 18 or more years
* No current diagnosed health conditions
* Not currently pregnant or breastfeeding

Arm 3
* Adults aged 18 or more years
* Diagnosed with anxiety.
* Not currently pregnant or breastfeeding
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any currently diagnosed health condition.
Pregnant and/or breastfeeding.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Non-parametric analysis of urinary kryptopyrrole (UKP) levels. Logistic regression used to investigate correlation between UKP levels and questionnaire (DASS-21) scores.

All data will be utilised with intention to treat analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2018
Actual
13/02/2018
Date of last participant enrolment
Anticipated
9/10/2018
Actual
31/12/2018
Date of last data collection
Anticipated
30/10/2018
Actual
16/01/2019
Sample size
Target
240
Accrual to date
Final
235
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18088 0
4006 - Fortitude Valley

Funding & Sponsors
Funding source category [1] 297976 0
Commercial sector/Industry
Name [1] 297976 0
SAFE Analytical Laboratories Pty Ltd
Country [1] 297976 0
Australia
Primary sponsor type
University
Name
Endeavour College of Natural Health Office of Research
Address
269 Wickham Street
Fortitude Valley Qld 4006
Country
Australia
Secondary sponsor category [1] 297045 0
None
Name [1] 297045 0
Address [1] 297045 0
Country [1] 297045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299014 0
Endeavour College of Natural Health Human Research Ethics Committee
Ethics committee address [1] 299014 0
269 Wickham Street
Fortitude Valley Qld 4006
Ethics committee country [1] 299014 0
Australia
Date submitted for ethics approval [1] 299014 0
10/11/2017
Approval date [1] 299014 0
30/11/2017
Ethics approval number [1] 299014 0
HREC #20171111

Summary
Brief summary
This study seeks to establish a reference range for a urinary kryptopyrrole test produced and conducted by SAFE Analytical Laboratories Pty Ltd ("the test"), This study is aiming to provide suitable data to enable registration of the test on the Australian Register of Therapeutic Goods (ARTG). Four parts to this study have been designed to correlate the urinary kryptopyrrole levels with health and disease states as observed in adult populations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78998 0
Dr Janet Schloss
Address 78998 0
Level 2, Endeavour College of Natural Health Office of Research
269 Wickham Street
Fortitude Valley Qld 4006
Country 78998 0
Australia
Phone 78998 0
+61 7 3253 9579
Fax 78998 0
Email 78998 0
[email protected]
Contact person for public queries
Name 78999 0
Janet Schloss
Address 78999 0
Level 2, Endeavour College of Natural Health Office of Research
269 Wickham Street
Fortitude Valley Qld 4006
Country 78999 0
Australia
Phone 78999 0
+61 7 3253 9579
Fax 78999 0
Email 78999 0
[email protected]
Contact person for scientific queries
Name 79000 0
Janet Schloss
Address 79000 0
Level 2, Endeavour College of Natural Health Office of Research
269 Wickham Street
Fortitude Valley Qld 4006
Country 79000 0
Australia
Phone 79000 0
+61 7 3253 9579
Fax 79000 0
Email 79000 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
Participants will be receiving direct pathological results to follow up with their healthcare practitioner. No individual data is shared with any other organisation.


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
SourceTitleYear of PublicationDOI
EmbaseVerifying the validity of urinary kryptopyrrole (UKP) testing in an adult population: Protocol for a multi-stage research project.2019https://dx.doi.org/10.1016/j.aimed.2019.02.001
EmbaseClinical significance and importance of elevated urinary kryptopyrroles (UKP): Self-reported observations and experience of Australian clinicians using UKP testing.2021https://dx.doi.org/10.1016/j.aimed.2021.04.002
N.B. These documents automatically identified may not have been verified by the study sponsor.