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Trial registered on ANZCTR
Registration number
ACTRN12613000210774
Ethics application status
Approved
Date submitted
19/02/2013
Date registered
21/02/2013
Date last updated
28/06/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Thyrotoxicosis: Assessment of ethnic differences in presentation and outcome
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Scientific title
Prospective, observational study assessing ethnic differences in the presentation and outcome of thyrotoxic patients presenting to a large New Zealand hospital
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Secondary ID [1]
281987
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Nil
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Universal Trial Number (UTN)
U1111-1139-6366
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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:
Thyrotoxicosis
288417
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Condition category
Condition code
Metabolic and Endocrine
288769
288769
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0
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Thyroid disease
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Public Health
288772
288772
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0
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Other public health
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Prospective, observational study assessing ethnic differences in rates, diagnosis and response to standard treatment for thyrotoxicosis. Thyrotoxicosis is an overactive thyroid gland with abnormal thyroid function on blood testing.
The rates of referrals for thyrotoxicosis for Maori, Pacific Island peoples and NZ europeans/Pakeha/other Europeans will be compared to that expected based on the demographics of the Waikato Hospital catchment area. The underlying cause of the thyrotoxicosis will be determined for each group and compared. The response to standard treatment (carbimazole) will be assessed after 12 months treatment as to whether there are ethnic differences in response. Similarly response to treatment after radioactive iodine therapy will be assessed 12 months after treatment. Recruitment will occur over a 3 year period with a minimum 12 months follow up for participants.
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Intervention code [1]
286557
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Not applicable
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Comparator / control treatment
Not applicable - observational study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
288903
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Rate of euthyroidism for Graves disease as determined by thyroid function tests obtained by peripheral blood samples
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Assessment method [1]
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Timepoint [1]
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12 months
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Primary outcome [2]
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Euthyroidism or hypothyroidism post-radioactive iodine therapy as determined by thyroid function tests obtained by peripheral blood samples
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Assessment method [2]
288904
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Timepoint [2]
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12 months
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Primary outcome [3]
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Rate of euthyroidism for toxic multinodular goitre as determined by thyroid function tests obtained by peripheral blood samples
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Assessment method [3]
288905
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Timepoint [3]
288905
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3 months
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Secondary outcome [1]
301308
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Percent shrinkage of goitre as measured by thyroid ultrasound scan
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Assessment method [1]
301308
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Timepoint [1]
301308
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12 months
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Eligibility
Key inclusion criteria
All patients presenting with thyrotoxicosis to Waikato Hospital
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Minimum age
18
Years
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Maximum age
No limit
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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
Pregnancy
Unable to consent
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2013
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Actual
1/03/2013
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Date of last participant enrolment
Anticipated
30/06/2015
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Actual
31/10/2014
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Date of last data collection
Anticipated
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Actual
12/02/2016
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Sample size
Target
530
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Accrual to date
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Final
353
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Recruitment outside Australia
Country [1]
4876
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New Zealand
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State/province [1]
4876
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Waikato
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Funding & Sponsors
Funding source category [1]
286766
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Hospital
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Name [1]
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Waikato Hospital
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Address [1]
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Pembroke Street Hamilton 3240
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Country [1]
286766
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New Zealand
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Funding source category [2]
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Government body
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Name [2]
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Health Research Council
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Address [2]
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PO Box 5541, Wellesley Street, Auckland 1141
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Country [2]
293930
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New Zealand
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Primary sponsor type
Individual
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Name
Dr Marianne Elston
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Address
Waikato Hospital
Private Bag 3200
Hamilton 3240
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Country
New Zealand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Associate Professor John V Conaglen
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Address [1]
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Waikato Hospital Private Bag 3200 Hamilton 3240
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Country [1]
285546
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288831
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Northern B Health and Disability Committee
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Ethics committee address [1]
288831
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Ministry of Health PO Box 5013 Wellington
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Ethics committee country [1]
288831
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New Zealand
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Date submitted for ethics approval [1]
288831
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Approval date [1]
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07/02/2013
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Ethics approval number [1]
288831
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13/NTB/4
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Summary
Brief summary
Thyrotoxicosis is a common endocrine disorder. When untreated, it leads to congestive heart failure, arrhythmias and premature death. There appear to be ethnic differences in the incidence, severity and presentation of thyrotoxicosis, although there is little published data to confirm this. Maori appear to be disproportionately over-represented in patients referred with thyrotoxicosis and have more severe disease. In addition, for Maori and Pacific peoples a single dose of radioactive iodine is less likely to be curative. The reasons for these apparent differences are unknown. The objective of this research is to confirm whether there are ethnic differences in the presentation and treatment outcome of thyrotoxicosis. We plan a prospective observational study to assess ethnic differences in the presentation, severity and response to treatment of all new patients referred with thyrotoxicosis. Results from this research may identify factors which enable us to individualise therapy for thyrotoxicosis and reduce disparities in outcome.
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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
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Dr Marianne Susan Elston
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Address
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Waikato Hospital Private Bag 3200 Hamilton 3240
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Country
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New Zealand
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Phone
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+6478398899
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Fax
37982
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Email
37982
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[email protected]
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Contact person for public queries
Name
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Jade Tamatea
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Address
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Waikato Hospital Private Bag 3200 Hamilton 3240
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Country
37983
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New Zealand
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Phone
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+6478398899
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Fax
37983
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Email
37983
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[email protected]
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Contact person for scientific queries
Name
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Jade Tamatea
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Address
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Waikato Hospital Private Bag 3200 Hamilton 3240
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Country
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New Zealand
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Phone
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+6478398899
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Dimensions AI
Thyrotoxicosis in an Indigenous New Zealand Population – a Prospective Observational Study
2020
https://doi.org/10.1210/jendso/bvaa002
N.B. These documents automatically identified may not have been verified by the study sponsor.
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