Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00111735




Registration number
NCT00111735
Ethics application status
Date submitted
24/05/2005
Date registered
25/05/2005
Date last updated
24/06/2005

Titles & IDs
Public title
Thyroxine Titration Study
Scientific title
What is the Optimal Serum TSH Concentration During Thyroxine Treatment for Primary Hypothyroidism? Effects of Fine Titration of Thyroxine Dosage on Wellbeing, Quality of Life and Cognitive Function
Secondary ID [1] 0 0
2003-015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypothyroidism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Thyroxine

Treatment: Drugs: Thyroxine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual analog scales assessing wellbeing
Timepoint [1] 0 0
Secondary outcome [1] 0 0
treatment satisfaction score
Timepoint [1] 0 0
Secondary outcome [2] 0 0
treatment preference
Timepoint [2] 0 0
Secondary outcome [3] 0 0
quality of life scores
Timepoint [3] 0 0
Secondary outcome [4] 0 0
cognitive function tests
Timepoint [4] 0 0
Secondary outcome [5] 0 0
clinical and biochemical markers of thyroid hormone action
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- Male or female subjects >18 years of age

- Primary hypothyroidism =6 months duration arising from autoimmune hypothyroidism,
thyroidectomy or radioiodine treatment

- Thyroxine dose =100 mcg/day

- No change in thyroxine dose in past 2 months

- Serum TSH of 0.1-4.8 mU/L

- Adequate contraceptive measures for women of childbearing age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Major systemic illness affecting quality of life or likely to affect participation in
the study

- Treatment with T3 currently or in past 2 months

- History of thyroid cancer requiring suppression of TSH secretion by thyroxine

- Ischaemic heart disease - previous myocardial infarction, angina or coronary artery
revascularisation

- Renal failure: serum creatinine >135 micromol/L

- Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference
range

- Bony fracture in past 3 months or Paget's disease of bone

- Secondary (central) hypothyroidism or hypopituitarism

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Sir Charles Gairdner Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to examine the effects of fine titration of thyroxine dosage on
symptoms of hypothyroidism, wellbeing and quality of life. The hypothesis is that symptoms of
hypothyroidism, wellbeing and quality of life will be improved in thyroxine-treated subjects
when serum thyrotropin (TSH) is suppressed and/or in the lower reference range, compared to
when TSH is in the upper reference range.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00111735
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00111735