Trial Review

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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
Scientific title
Prospective, observational study assessing ethnic differences in the presentation and outcome of thyrotoxic patients presenting to a large New Zealand hospital
Secondary ID [1] 281987 0
Nil
Universal Trial Number (UTN)
U1111-1139-6366
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyrotoxicosis 288417 0
Condition category
Condition code
Metabolic and Endocrine 288769 288769 0 0
Thyroid disease
Public Health 288772 288772 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 286557 0
Not applicable
Comparator / control treatment
Not applicable - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288903 0
Rate of euthyroidism for Graves disease
as determined by thyroid function tests obtained by peripheral blood samples
Timepoint [1] 288903 0
12 months
Primary outcome [2] 288904 0
Euthyroidism or hypothyroidism post-radioactive iodine therapy as determined by thyroid function tests obtained by peripheral blood samples
Timepoint [2] 288904 0
12 months
Primary outcome [3] 288905 0
Rate of euthyroidism for toxic multinodular goitre as determined by thyroid function tests obtained by peripheral blood samples
Timepoint [3] 288905 0
3 months
Secondary outcome [1] 301308 0
Percent shrinkage of goitre as measured by thyroid ultrasound scan
Timepoint [1] 301308 0
12 months

Eligibility
Key inclusion criteria
All patients presenting with thyrotoxicosis to Waikato Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Unable to consent

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
1/03/2013
Date of last participant enrolment
Anticipated
30/06/2015
Actual
31/10/2014
Date of last data collection
Anticipated
Actual
12/02/2016
Sample size
Target
530
Accrual to date
Final
353
Recruitment outside Australia
Country [1] 4876 0
New Zealand
State/province [1] 4876 0
Waikato

Funding & Sponsors
Funding source category [1] 286766 0
Hospital
Name [1] 286766 0
Waikato Hospital
Country [1] 286766 0
New Zealand
Funding source category [2] 293930 0
Government body
Name [2] 293930 0
Health Research Council
Country [2] 293930 0
New Zealand
Primary sponsor type
Individual
Name
Dr Marianne Elston
Address
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 285546 0
Individual
Name [1] 285546 0
Associate Professor John V Conaglen
Address [1] 285546 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country [1] 285546 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288831 0
Northern B Health and Disability Committee
Ethics committee address [1] 288831 0
Ministry of Health
PO Box 5013
Wellington
Ethics committee country [1] 288831 0
New Zealand
Date submitted for ethics approval [1] 288831 0
Approval date [1] 288831 0
07/02/2013
Ethics approval number [1] 288831 0
13/NTB/4

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37982 0
Dr Marianne Susan Elston
Address 37982 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 37982 0
New Zealand
Phone 37982 0
+6478398899
Fax 37982 0
Email 37982 0
Marianne.Elston@waikatodhb.health.nz
Contact person for public queries
Name 37983 0
Jade Tamatea
Address 37983 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 37983 0
New Zealand
Phone 37983 0
+6478398899
Fax 37983 0
Email 37983 0
Jade.Tamatea@waikatodhb.health.nz
Contact person for scientific queries
Name 37984 0
Jade Tamatea
Address 37984 0
Waikato Hospital
Private Bag 3200
Hamilton 3240
Country 37984 0
New Zealand
Phone 37984 0
+6478398899
Fax 37984 0
Email 37984 0
Jade.Tamatea@waikatodhb.health.nz

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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3798Basic resultsNo 363731-(Uploaded-27-11-2019-13-31-40)-Basic results summary.docx

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThyrotoxicosis in an Indigenous New Zealand Population – a Prospective Observational Study2020https://doi.org/10.1210/jendso/bvaa002
N.B. These documents automatically identified may not have been verified by the study sponsor.