Protocol summary
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Study aim
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The aim of this study is to investigate the effectiveness of two different regimens of continuous Methimazole treatment in comparison to radioactive iodine and to compare health status, and results of neuro-psychological testing in patients receiving long-term continuous Methimazole to those of patients on replacement thyroxine doses following radioiodine-induced hypothyroidism.
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Design
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Patients will be assigned to the respective groups and samples will be obtained at baseline. The radio-iodine group patients will be followed up every 12 months for the duration of treatment.
Patients in the "Methimazole" group will further be randomly assigned to either "Conventional Length" or "Long-term" groups and will be followed up every 6 months.
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Settings and conduct
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Consecutive patients with untreated first episodes of Graves’ hyperthyroidism who fulfill the inclusion criteria and do not have any of the exclusion criteria are recruited from among those who present to an expert private clinic in Tehran over the span of the trial. After allocation to respective groups, the patients will be followed up according to the respective protocol.
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Participants/Inclusion and exclusion criteria
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A minimum of 239 patients with diffuse toxic goiter who experience recurrence of hyperthyroidism and are referred to an expert private clinic are recruited.
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Intervention groups
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"Radioactive Iodine Group" and "Methimazole Group".
Under the "Methimazole Group" there are two more groups:
"Conventional Group" and "Long-term" groups.
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Main outcome variables
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The primary endpoint is relapse of overt hyperthyroidism after methimazole or radioiodine discontinuation. Key secondary endpoints are occurrence of subclinical hyperthyroidism or overt or subclinical hypothyroidism during or after the treatment modality received.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201009224794N1
Registration date:
2010-10-25, 1389/08/03
Registration timing:
registered_while_recruiting
Last update:
2019-02-22, 1397/12/03
Update count:
1
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Registration date
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2010-10-25, 1389/08/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Governmental: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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1990-03-01, 1368/12/10
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Expected recruitment end date
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2009-07-01, 1388/04/10
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Actual recruitment start date
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1990-03-01, 1368/12/10
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Actual recruitment end date
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2012-03-02, 1390/12/12
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Trial completion date
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2017-03-10, 1395/12/20
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Scientific title
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Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism
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Public title
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Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age older than 19 years
Biochemically defined overt hyperthyroidism
No history or evidence of cardiovascular diseases
No history or evidence of chronic heart failure
No history or evidence of chronic kidney disease
No history or evidence of cirrhosis
Exclusion criteria:
Evidence of pregnancy
Evidence of breast-feeding
Evidence of altered mental function
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Age
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From 19 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
239
Actual sample size reached:
302
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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1:1 simple randomization using the Table of Random Digits to intervention groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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The methimazole arm of the trial is further randomized to either continue methimazole treatment for an additional period to reach a total of 60 to 120 months (the "long-term" group), or discontinue treatment after the conventional period of 18 to 24 months of treatment (the "conventional" group). This randomization is also done through using the Table of Random Digits.
Ethics committees
1
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Ethics committee
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Approval date
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2010-03-02, 1388/12/11
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Ethics committee reference number
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275EC
Health conditions studied
1
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Description of health condition studied
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Hyperthyroidism
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ICD-10 code
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E05
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ICD-10 code description
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Thyrotoxicosis [hyperthyroidism]
2
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Description of health condition studied
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anti-thyroid drugs
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Neuro-psychologic condition
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Timepoint
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at the beginning and end of study
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Method of measurement
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neuro-psychologic tests
2
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Description
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Development of Goiter
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Timepoint
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any visit and at the end of study
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Method of measurement
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physical exam
3
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Description
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Thyroid function assessment
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Timepoint
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Every 6 months during follow up and at the end of study
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Method of measurement
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laboratory
4
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Description
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Cardiac function
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Timepoint
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at the end of study
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Method of measurement
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echocardiography
Secondary outcomes
1
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Description
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Serum lipid profiles
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Timepoint
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at the beginning and end of study (during study if needed)
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Method of measurement
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laboratory
2
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Description
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bone mineral density
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Timepoint
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at the end of study
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Method of measurement
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BMD
3
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Description
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cost
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Timepoint
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During follow up and at the end of study
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Method of measurement
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from actual ambulatory and hospital expenses during follow up
Intervention groups
1
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Description
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100 µCi iodide 131 per gram of the thyroid In "radioiodine group"
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Category
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Treatment - Other
2
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Description
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Methimazole group: 10 mg of Methimazole twice daily during the first month and 10 mg daily during the second month of therapy. Maintenance doses of 2.5–10 mg daily from the third month onward.
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Category
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Treatment - Drugs
3
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Description
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"Conventional Methimazole Group": "Methimazole" for the conventional period of time, that is 18 to 24 months, as per the description provided for the main methimazole arm.
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Category
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Treatment - Drugs
4
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Description
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"Long-term Methimazole Group": "Methimazole" for a period of time in addition to the conventional period of 18 to 24 months so that the total duration of treatment with methimazole will be 60 to 120 months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Independent Research grant
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Grant code / Reference number
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797
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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De-identified data will be shared with academic centers and investigators for the purpose of meta-analyses.
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When the data will become available and for how long
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12 months after publication of the results.
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To whom data/document is available
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Academic investigators
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Under which criteria data/document could be used
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Criteria set forthby international consortia on meta-analyses and IPD-MA
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From where data/document is obtainable
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The Research Institute for Endocrine Sciences (RIES)
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What processes are involved for a request to access data/document
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Request from the PI at the RIES and approval of the legal department.
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Comments
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