]>
IRCT201009224794N1 IRCT 2010-10-25 Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism 1990-03-01 anticipated 239 Complete https://irct.ir/trial/5143 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: 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, Randomization description: 1:1 simple randomization using the Table of Random Digits to intervention groups. 2-3 Condition 1: Hyperthyroidism. Condition 2: anti-thyroid drugs. Intervention 1: 100 µCi iodide 131 per gram of the thyroid In "radioiodine group". Intervention 2: 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. Intervention 3: "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. Intervention 4: "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. Yes - There is a plan to make this available What will be shared: De-identified data will be shared with academic centers and investigators for the purpose of meta-analyses. When: 12 months after publication of the results. To whom: Academic investigators Conditions: Criteria set forthby international consortia on meta-analyses and IPD-MA Where to obtain: The Research Institute for Endocrine Sciences (RIES) How to obtain: Request from the PI at the RIES and approval of the legal department. Comments:
public Fereidoun Azizi, M.D.
Next to Taleghani Hospital, Velenjak
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2240 9309 azizi@endocrine.ac.ir Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Siences scientific Fereidoun Azizi, M.D.
Next to Taleghani Hospital, Velenjak
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2240 9309 azizi@endocrine.ac.ir Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 19 years no limit Both Evidence of pregnancy Evidence of breast-feeding Evidence of altered mental function E05 Thyrotoxicosis [hyperthyroidism] Treatment - Other Treatment - Drugs Treatment - Drugs Treatment - Drugs 100 µCi iodide 131 per gram of the thyroid In "radioiodine group" 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. "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. "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. Neuro-psychologic condition. Timepoint: at the beginning and end of study. Method of measurement: neuro-psychologic tests. Development of Goiter. Timepoint: any visit and at the end of study. Method of measurement: physical exam. Thyroid function assessment. Timepoint: Every 6 months during follow up and at the end of study. Method of measurement: laboratory. Cardiac function. Timepoint: at the end of study. Method of measurement: echocardiography. Serum lipid profiles. Timepoint: at the beginning and end of study (during study if needed). Method of measurement: laboratory. Bone mineral density. Timepoint: at the end of study. Method of measurement: BMD. Cost. Timepoint: During follow up and at the end of study. Method of measurement: from actual ambulatory and hospital expenses during follow up. Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences Approved 2010-03-02 Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Next to Talegani Hospital, Velenjak Tehran Tehran Iran (Islamic Republic of)