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Protocol summary
The aim of this study was to investigate the effectiveness of continuous Methimazole treatment and to compare health status, and results of neuropsychological testing in patients receiving long-term continuous Methimazole to those of patients on replacement thyroxine doses following radioiodine-induced hypothyrodidm. We enrolled 239 patients with diffuse toxic goiter who had recurrence of hyperthyroidism and had been referred to an expert private clinic. One hundred and four patients were randomized into two, the methimazole and the radioiodine treatment groups. The remaining 135 patients voluntarily enrolled into two groups. After monthly visits for the first 3 months of therapy, all patients in both groups were visited every 3 months for the first year and, every 6 months thereafter. The following measurements were done for both groups: 1- questionnaires 2- physical exam and determining thyroid size 3- TSH, T3, FT4, anti TPO and TSI 4- serum lipids 5- cardiac function 6- bone mineral density 7- Neuro-psychology tests 8- treatment costs.
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The aim of this study was to investigate the effectiveness of continuous Methimazole treatment and to compare health status, and results of neuropsychological testing in patients receiving long-term continuous Methimazole to those of patients on replacement thyroxine doses following radioiodine-induced hypothyrodidm. We enrolled 239 patients with diffuse toxic goiter who had recurrence of hyperthyroidism and had been referred to an expert private clinic. One hundred and four patients were randomized into two, the methimazole and the radioiodine treatment groups. The remaining 135 patients voluntarily enrolled into two groups. After monthly visits for the first 3 months of therapy, all patients in both groups were visited every 3 months for the first year and, every 6 months thereafter. The following measurements were done for both groups: 1- questionnaires 2- physical exam and determining thyroid size 3- TSH, T3, FT4, anti TPO and TSI 4- serum lipids 5- cardiac function 6- bone mineral density 7- Neuro-psychology tests 8- treatment costs.
هدف از این مطالعه مقايسه اثرات درمان طولاني مدت با متي مازول با يد راديواكتيو در پركاري تيروئيد بود. تعداد 239 بیمار پرکاری تیرویید که دچار عود بیماری شده و به مطب فوق تخصصی غدد ارجاع شده بودند وارد مطالعه شدند. 104 بیمار به طور تصادفی به دو گروه درمان دائم با متی مازول و درمان با يد راديواكتيو تقسیم شدند. همچنین تعداد 135 بیمار به انتخاب خود در گروه ها قرار گرفتند. بیماران هر ماه تا 3 ماه، هر 3 ماه تا یکسال و سپس هر 6 ماه پیگیری شدند. موارد زير در هر دو گروه انجام شد: 1- تكميل پرسشنامه‌ها 2- معاينه باليني و تعيين اندازه تيروئيد 3- تستهاي غلظت FT4، T3، TSH آنتي‌بادي ضد TPO و TSI 4- غلظت ليپيدهاي سرم 5- تستهاي عملكرد قلبي 6- تراكم استخوان 7- تستهاي رواني عصبي حركتي 8- هزینه های درمانی.
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هدف از این مطالعه مقايسه اثرات درمان طولاني مدت با متي مازول با يد راديواكتيو در پركاري تيروئيد بود. تعداد 239 بیمار پرکاری تیرویید که دچار عود بیماری شده و به مطب فوق تخصصی غدد ارجاع شده بودند وارد مطالعه شدند. 104 بیمار به طور تصادفی به دو گروه درمان دائم با متی مازول و درمان با يد راديواكتيو تقسیم شدند. همچنین تعداد 135 بیمار به انتخاب خود در گروه ها قرار گرفتند. بیماران هر ماه تا 3 ماه، هر 3 ماه تا یکسال و سپس هر 6 ماه پیگیری شدند. موارد زير در هر دو گروه انجام شد: 1- تكميل پرسشنامه‌ها 2- معاينه باليني و تعيين اندازه تيروئيد 3- تستهاي غلظت FT4، T3، TSH آنتي‌بادي ضد TPO و TSI 4- غلظت ليپيدهاي سرم 5- تستهاي عملكرد قلبي 6- تراكم استخوان 7- تستهاي رواني عصبي حركتي 8- هزینه های درمانی.
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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.
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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هدف اصلی این مطالعه بررسی اثرگذاری دو رژیم متفاوت دز پیوسته متی مازول در مقایسه با ید رادیواکتیو از نظر وضعیت عمومی سلامت، نتایج آزمایشات نوروسایکولوژیک در این دو مودالیته درمانی می باشد.
هدف اصلی این مطالعه بررسی اثرگذاری دو رژیم متفاوت دز پیوسته متی مازول در مقایسه با ید رادیواکتیو از نظر وضعیت عمومی سلامت، نتایج آزمایشات نوروسایکولوژیک در این دو مودالیته درمانی می باشد.
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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.
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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بیماران به گروه های مربوطه فرستاده می شوند و نمونه گیری های اولیه از آنان بعمل خواهد آمد. گروه "ید رادیواکتیو" در طول مدت درمان هر 12 ماه یک بار پیگیری می شوند.
بیماران "متی مازول" به طور تصادفي به دو گروه "درمان معمول" و "درمان طولاني مدت" تقسيم مي شوند و بيماران در اين گروه هر 6 ماه پیگیری می شوند.
بیماران به گروه های مربوطه فرستاده می شوند و نمونه گیری های اولیه از آنان بعمل خواهد آمد. گروه "ید رادیواکتیو" در طول مدت درمان هر 12 ماه یک بار پیگیری می شوند. بیماران "متی مازول" به طور تصادفي به دو گروه "درمان معمول" و "درمان طولاني مدت" تقسيم مي شوند و بيماران در اين گروه هر 6 ماه پیگیری می شوند.
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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.
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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بیماران مراجعه کننده با اولین دوره عود هیپرتیروییدی گریوز که مشمول شرایط ورود می شوند و هیچ کدام از شرایط خروج را ندارند و به یک کلینیک فوق تخصصی مراجعه کرده اند. پس از تخصیص بیماران به گروه های مربوطه بیماران بر اساس پروتکل گروه خود پیگیری می شوند.
بیماران مراجعه کننده با اولین دوره عود هیپرتیروییدی گریوز که مشمول شرایط ورود می شوند و هیچ کدام از شرایط خروج را ندارند و به یک کلینیک فوق تخصصی مراجعه کرده اند. پس از تخصیص بیماران به گروه های مربوطه بیماران بر اساس پروتکل گروه خود پیگیری می شوند.
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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.
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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دست کم 239 بیمار با گواتر سمی که مبتلا به عود هیپرتیروییدی شده اند از میان مراجعه کنندگان به یک کلینیک فوق تخصصی غدد در مطالعه وارد می شوند.
دست کم 239 بیمار با گواتر سمی که مبتلا به عود هیپرتیروییدی شده اند از میان مراجعه کنندگان به یک کلینیک فوق تخصصی غدد در مطالعه وارد می شوند.
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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.
"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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دو گروه "متی مازول" و "ید رادیواکتیو".
در "گروه متي مازول" دو گروه ديگر خواهند بود:
"گروه درمان معمول" و "گروه درمان طولانی مدت".
دو گروه "متی مازول" و "ید رادیواکتیو". در "گروه متي مازول" دو گروه ديگر خواهند بود: "گروه درمان معمول" و "گروه درمان طولانی مدت".
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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.
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.
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نتیجه اصلی مورد مطالعه عود هیپرتیروییدی بارز بعد از قطع متی مازول یا ید رادیواکتیو می باشد.
نتایج مورد نظر دیگر عبارتند از بروز هیپرتیروییدی ساب-کلینیکال، یا هیپوتیروییدی ساب-کلینیکال یا بارز در طول، و یا بعد از، دریافت درمان.
نتیجه اصلی مورد مطالعه عود هیپرتیروییدی بارز بعد از قطع متی مازول یا ید رادیواکتیو می باشد. نتایج مورد نظر دیگر عبارتند از بروز هیپرتیروییدی ساب-کلینیکال، یا هیپوتیروییدی ساب-کلینیکال یا بارز در طول، و یا بعد از، دریافت درمان.
General information
21
19
2119
75
empty
75
Year
empty
year
No
Yes
1
Single blinded
Not blinded
singlnotbl
No
No
empty
0
0
empty
302
302
No
No
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1990-03-01, 1368/12/10
1990-03-01 00:00:00
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2012-03-02, 1390/12/12
2012-03-02 00:00:00
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2017-03-10, 1395/12/20
2017-03-10 00:00:00
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
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
سن بالای 19 سال
هیپرتیروییدیسم بارز با تعاریف بیوشیمیایی
نبود سابقه یا شواهدی دال بر بیماریهای قلبی و عروقی
نبود سابقه یا شواهدی دال بر نارسایی مزمن قلبی
نبود سابقه یا شواهدی دال بر بیماری مزمن کلیوی
نبود سابقه یا شواهدی دال بر سیروز کبدی
سن بالای 19 سال هیپرتیروییدیسم بارز با تعاریف بیوشیمیایی نبود سابقه یا شواهدی دال بر بیماریهای قلبی و عروقی نبود سابقه یا شواهدی دال بر نارسایی مزمن قلبی نبود سابقه یا شواهدی دال بر بیماری مزمن کلیوی نبود سابقه یا شواهدی دال بر سیروز کبدی
Evidence of pregnancy
Evidence of breast-feeding
Evidence of altered mental function
Evidence of pregnancy Evidence of breast-feeding Evidence of altered mental function
حاملگی
شیردهی
شواهد اختلال عملکرد ذهنی
حاملگی شیردهی شواهد اختلال عملکرد ذهنی
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.
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.
گروه "متي مازول" اين كارآزمايي به طور تصادفي به دو گروه تقسيم مي شوند. يك گروه درمان را بعد از دوره اوليه قطع مي كنند ("گروه درمان معمول") و گروه ديگر به مدت بيشتري درمان را ادامه مي دهند به نحوي كه مجموع طول دوره درمان با متي مازول به ٦٠ تا ١٢٠ ماه برسد ("گروه درمان طولاني مدت"). اين تقسيم تصادفي نيز بر اساس جدول اعداد تصادفي صورت مي گيرد.
گروه "متي مازول" اين كارآزمايي به طور تصادفي به دو گروه تقسيم مي شوند. يك گروه درمان را بعد از دوره اوليه قطع مي كنند ("گروه درمان معمول") و گروه ديگر به مدت بيشتري درمان را ادامه مي دهند به نحوي كه مجموع طول دوره درمان با متي مازول به ٦٠ تا ١٢٠ ماه برسد ("گروه درمان طولاني مدت"). اين تقسيم تصادفي نيز بر اساس جدول اعداد تصادفي صورت مي گيرد.
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1:1 simple randomization using the Table of Random Digits to intervention groups.
1:1 simple randomization using the Table of Random Digits to intervention groups.
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تصادفی سازی 1:1 ساده به گروه های مداخله با استفاده از جدول اعداد تصادفی.
تصادفی سازی 1:1 ساده به گروه های مداخله با استفاده از جدول اعداد تصادفی.
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Primary outcomes
#1
Goiter
Development of Goiter
Development of Goiter
گواتر
ايجاد گواتر
ايجاد گواتر
#2
Thyroid function
Thyroid function assessment
Thyroid function assessment
درست كاري تيروئيد
ارزيابي درست كاري تيروئيد
ارزيابي درست كاري تيروئيد
during follow up and at the end of study
Every 6 months during follow up and at the end of study
Every 6 months during follow up and at the end of study
در طی پیگیری و در انتها
هر ٦ ماه در طی پیگیری و در انتها
هر ٦ ماه در طی پیگیری و در انتها
Secondary outcomes
#1
lipid profiles
Serum lipid profiles
Serum lipid profiles
سطح ليپيدهاي
سطح سرمي ليپيدها
سطح ليپيدهايسرمي ليپيدها
Intervention groups
#1
In radioiodine group, patients received 100 µCi 131I per gram of the thyroid
100 µCi iodide 131 per gram of the thyroid In "radioiodine group"
In radioiodine group, patients received 100 µCi 131Iiodide 131 per gram of the thyroid In "radioiodine group"
در گروه يد100 ميكرو كوري يد 131 آي براي هر گرم تيروئيد
در "گروه يد": ١٠٠ ميكرو كوري يد 131 آي براي هر گرم تيروئيد
در "گروه يد100يد": ١٠٠ ميكرو كوري يد 131 آي براي هر گرم تيروئيد
#2
In the Methimazole group, patients received 10 mg of Methimazole twice daily during the first month and 10 mg daily during the second month of therapy. All patients received maintenance doses of 2.5–10 mg daily from the third month on
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.
In the Methimazole group, patients received: 10 mg of Methimazole twice daily during the first month and 10 mg daily during the second month of therapy. All patients received maintenanceMaintenance doses of 2.5–10 mg daily from the third month ononward.
در گروه متی مازول 10 میلی گرم متی مازول دو بار در روز در ماه اول و سپس 10 میلی گرم در روز برای ماه دوم و از ماه سوم به بعد 2.5 الی 10 میلی گرم روزانه
گروه متی مازول: 10 میلی گرم متی مازول دو بار در روز در ماه اول و سپس 10 میلی گرم در روز برای ماه دوم و از ماه سوم به بعد 2.5 الی 10 میلی گرم روزانه
در گروه متی مازول: 10 میلی گرم متی مازول دو بار در روز در ماه اول و سپس 10 میلی گرم در روز برای ماه دوم و از ماه سوم به بعد 2.5 الی 10 میلی گرم روزانه
#3
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Treatment - Drugs
treatment-drugs
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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.
"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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"گروه متی مازول معمول": داروی متی مازول تنها به مدت معمول در مقالات، یعنی 18 تا 24 ماه، طبق آنچه که در مورد متی مازول در گروه اصلی گفته شد دریافت می کنند.
"گروه متی مازول معمول": داروی متی مازول تنها به مدت معمول در مقالات، یعنی 18 تا 24 ماه، طبق آنچه که در مورد متی مازول در گروه اصلی گفته شد دریافت می کنند.
#4
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Treatment - Drugs
treatment-drugs
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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.
"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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"گروه متی مازول طولانی مدت": متی مازول علاوه بر مدت معمول ، یعنی 18 تا 24 ماه، برای مدتی طولانی تر تجویز می شود به طوریکه مجموع مدت درمان در این گروه بین 60 تا 120 ماه خواهد بود.
"گروه متی مازول طولانی مدت": متی مازول علاوه بر مدت معمول ، یعنی 18 تا 24 ماه، برای مدتی طولانی تر تجویز می شود به طوریکه مجموع مدت درمان در این گروه بین 60 تا 120 ماه خواهد بود.
Recruitment centers
#1
Name of recruitment center - English: Dr. Azizi's Private Clinic
Name of recruitment center - Persian: مطب شخصي دكتر فريدون عزيزي
Full name of responsible person - English: Fereidoun Azizi, M.D.
Full name of responsible person - Persian: دكتر فريدون عزيزي
Street address - English:
Street address - Persian:
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Dr. Azizi's Private Clinic
Name of recruitment center - Persian: مطب شخصي دكتر فريدون عزيزي
Full name of responsible person - English: Fereidoun Azizi, M.D.
Full name of responsible person - Persian: دكتر فريدون عزيزي
Street address - English: Sa'aadat Abad, Riazi Bakhshayesh St., Erfan Hospital
Street address - Persian: سعادت آباد، بین چهارراه سرو و بلوار شهرداری، خیابان شهید ریاضی بخشایش، بیمارستان عرفان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 19986
Phone: +98 21 2240 9309
Fax:
Email: azizi@endocrine.ac.ir
Web page address: http://erfanhospital.ir/en/Departments/Paraclinics/Endocrinology-Clinic
Name of recruitment center - English: Dr. Azizi's Private Clinic Name of recruitment center - Persian: مطب شخصي دكتر فريدون عزيزي Full name of responsible person - English: Fereidoun Azizi, M.D. Full name of responsible person - Persian: دكتر فريدون عزيزي Street address - English: Sa'aadat Abad, Riazi Bakhshayesh St., Erfan Hospital Street address - Persian: سعادت آباد، بین چهارراه سرو و بلوار شهرداری، خیابان شهید ریاضی بخشایش، بیمارستان عرفان City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 19986 Phone: +98 21 2240 9309 Fax: Email: azizi@endocrine.ac.ir Web page address: http://erfanhospital.ir/en/Departments/Paraclinics/Endocrinology-Clinic
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Azita Zadeh Vakili, PhD
Full name of responsible person - Persian: دکتر آزیتا زاده وکیلی
Street address - English: Next to Taleghani Hospital,Velenjak
Street address - Persian: ولنجک، جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Azita Zadeh Vakili, PhD
Full name of responsible person - Persian: دکتر آزیتا زاده وکیلی
Street address - English: Next to Taleghani Hospital,Velenjak
Street address - Persian: ولنجک، جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2240 9309
Fax:
Email: vakili@endocrine.ac.ir
Web page address: http://www.endocrine.ac.ir
contact.organization_id: Name of organization / entity - English: Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي Full name of responsible person - English: Azita Zadeh Vakili, PhD Full name of responsible person - Persian: دکتر آزیتا زاده وکیلی Street address - English: Next to Taleghani Hospital,Velenjak Street address - Persian: ولنجک، جنب بيمارستان طالقاني City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 2240 9309 Fax: Email: vakili@endocrine.ac.ir Web page address: http://www.endocrine.ac.ir
797
797
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Independent Research grant
Independent Research grant
طرح پژوهشی مستقل
طرح پژوهشی مستقل
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Siences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Fereidoun Azizi, M.D.
Full name of responsible person - Persian: دكتر فريدون عزيزي
Position - English: Director
Position - Persian: رييس
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Next to Taleghani Hospital, Velenjak
Street address - Persian: ولنجك، جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2240 9309
Mobile:
Fax:
Email: azizi@endocrine.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Siences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Fereidoun Azizi, M.D.
Full name of responsible person - Persian: دكتر فريدون عزيزي
Position - English: Director
Position - Persian: رييس
Latest degree: sub_specialist
Area of specialty/work: 40
Area of specialty/work title - English: Endocrinology
Area of specialty/work title - Persian: آندوکرینولوژی
Street address - English: Next to Taleghani Hospital, Velenjak
Street address - Persian: ولنجك، جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2240 9309
Mobile: +98 912 501 7641
Fax:
Email: azizi@endocrine.ac.ir
Web page address: http://www.endocrine.ac.ir
contact.organization_id: Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Siences Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي Full name of responsible person - English: Fereidoun Azizi, M.D. Full name of responsible person - Persian: دكتر فريدون عزيزي Position - English: Director Position - Persian: رييس Latest degree: sub_specialist Area of specialty/work: 040 Area of specialty/work title - English: Endocrinology Area of specialty/work title - Persian: آندوکرینولوژی Street address - English: Next to Taleghani Hospital, Velenjak Street address - Persian: ولنجك، جنب بيمارستان طالقاني City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 2240 9309 Mobile: +98 912 501 7641 Fax: Email: azizi@endocrine.ac.ir Web page address: http://www.endocrine.ac.ir
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Fereidoun Azizi, M.D.
Full name of responsible person - Persian: دکتر فریدون عزیزی
Position - English: Director/ professor of Internal Medicine and Endocrinology
Position - Persian: رئيس/استاد طب داخلي وغدد درن ريز و متابوليسم
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Next to Taleghani Hospital, Velenjak
Street address - Persian: ولنجك- جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2240 9309
Mobile:
Fax:
Email: azizi@endocrine.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Fereidoun Azizi, M.D.
Full name of responsible person - Persian: دکتر فریدون عزیزی
Position - English: Director/ professor of Internal Medicine and Endocrinology
Position - Persian: رئيس/استاد طب داخلي وغدد درن ريز و متابوليسم
Latest degree: sub_specialist
Area of specialty/work: 40
Area of specialty/work title - English: Endocrinology
Area of specialty/work title - Persian: آندوکرینولوژی
Street address - English: Next to Taleghani Hospital, Velenjak
Street address - Persian: ولنجك- جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2240 9309
Mobile: +98 912 501 7641
Fax:
Email: azizi@endocrine.ac.ir
Web page address: http://www.endocrine.ac.ir
contact.organization_id: Name of organization / entity - English: Research Institute for Endocrine Sciences,Shahid Beheshti University of Medical Sciences Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي Full name of responsible person - English: Fereidoun Azizi, M.D. Full name of responsible person - Persian: دکتر فریدون عزیزی Position - English: Director/ professor of Internal Medicine and Endocrinology Position - Persian: رئيس/استاد طب داخلي وغدد درن ريز و متابوليسم Latest degree: sub_specialist Area of specialty/work: 040 Area of specialty/work title - English: Endocrinology Area of specialty/work title - Persian: آندوکرینولوژی Street address - English: Next to Taleghani Hospital, Velenjak Street address - Persian: ولنجك- جنب بيمارستان طالقاني City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 2240 9309 Mobile: +98 912 501 7641 Fax: Email: azizi@endocrine.ac.ir Web page address: http://www.endocrine.ac.ir
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Seyed Vahid Yousefi, M.D.
Full name of responsible person - Persian: دكتر سيد وحيد يوسفي
Position - English: Endocrinologist
Position - Persian: فوق تخصص غدد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Next to Taleghani Hospital, Velenjak
Street address - Persian: ولنجك جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: IRAN
Phone: +98 21 2243 2500
Mobile:
Fax:
Email: sv1yousefi@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي
Full name of responsible person - English: Miralireza Takyar, MD PhD
Full name of responsible person - Persian: دكتر میرعلیرضا تکیار
Position - English: Physician-Scientist
Position - Persian: پزشک پژوهشگر
Latest degree: phd
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Next to Taleghani Hospital, Velenjak
Street address - Persian: ولنجك جنب بيمارستان طالقاني
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: IRAN
Phone: +98 21 2243 2500
Mobile: +98 912 501 7641
Fax:
Email: takyar@endocrine.ac.ir
Web page address: http://www.endocrine.ac.ir
contact.organization_id: Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Name of organization / entity - Persian: پژوهشكده علوم غدد درون‌ريز و متابوليسم ـ دانشگاه علوم پزشكي شهيد بهشتي Full name of responsible person - English: Seyed Vahid YousefiMiralireza Takyar, M.D.MD PhD Full name of responsible person - Persian: دكتر سيد وحيد يوسفيمیرعلیرضا تکیار Position - English: EndocrinologistPhysician-Scientist Position - Persian: فوق تخصص غددپزشک پژوهشگر Latest degree: phd Area of specialty/work: 040 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Next to Taleghani Hospital, Velenjak Street address - Persian: ولنجك جنب بيمارستان طالقاني City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: IRAN Phone: +98 21 2243 2500 Mobile: +98 912 501 7641 Fax: Email: sv1yousefitakyar@yahoo.comendocrine.ac.ir Web page address: http://www.endocrine.ac.ir
Sharing plan
yes
yes
yes
yes
yes
yes
undecided
undecided
undecided
undecided
undecided
undecided
yes
yes
empty
De-identified data will be shared with academic centers and investigators for the purpose of meta-analyses.
De-identified data will be shared with academic centers and investigators for the purpose of meta-analyses.
empty
داده هاي غیر قابل شناسايي با مراكز و محققين آكادميك به منظور انجام متاآناليز ها به اشتراك گذاشته خواهد شد.
داده هاي غیر قابل شناسايي با مراكز و محققين آكادميك به منظور انجام متاآناليز ها به اشتراك گذاشته خواهد شد.
empty
12 months after publication of the results.
12 months after publication of the results.
empty
١٢ ماه پس از تاريخ انتشار يافته ها.
١٢ ماه پس از تاريخ انتشار يافته ها.
empty
Academic investigators
Academic investigators
empty
محققين آكادميك.
محققين آكادميك.
empty
Criteria set forthby international consortia on meta-analyses and IPD-MA
Criteria set forthby international consortia on meta-analyses and IPD-MA
empty
شرايط بيان شده توسط مجامع بين المللي متاآناليز و IPD-MA
شرايط بيان شده توسط مجامع بين المللي متاآناليز و IPD-MA
empty
The Research Institute for Endocrine Sciences (RIES)
The Research Institute for Endocrine Sciences (RIES)
empty
پژوهشكده علوم غدد درون ريز
پژوهشكده علوم غدد درون ريز
empty
Request from the PI at the RIES and approval of the legal department.
Request from the PI at the RIES and approval of the legal department.
empty
درخواست از پژوهشگر مسئول كارآزمايي و تائيد دپارتمان حقوقي پژوهشكده
درخواست از پژوهشگر مسئول كارآزمايي و تائيد دپارتمان حقوقي پژوهشكده
Protocol summary
Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
A minimum of 239 patients with diffuse toxic goiter who experience recurrence of hyperthyroidism and are referred to an expert private clinic are recruited.
Intervention groups
"Radioactive Iodine Group" and "Methimazole Group".
Under the "Methimazole Group" there are two more groups:
"Conventional Group" and "Long-term" groups.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
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
Registration date
2010-10-25, 1389/08/03
Registrant information
Name
Fereidoun Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
azizi@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
1990-03-01, 1368/12/10
Expected recruitment end date
2009-07-01, 1388/04/10
Actual recruitment start date
1990-03-01, 1368/12/10
Actual recruitment end date
2012-03-02, 1390/12/12
Trial completion date
2017-03-10, 1395/12/20
Scientific title
Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism
Public title
Long-term Continuous Methimazole or Radioiodine Treatment for Hyperthyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 19 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
239
Actual sample size reached:
302
Randomization (investigator's opinion)
Randomized
Randomization description
1:1 simple randomization using the Table of Random Digits to intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Street address
Next to Talegani Hospital, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2010-03-02, 1388/12/11
Ethics committee reference number
275EC
Health conditions studied
1
Description of health condition studied
Hyperthyroidism
ICD-10 code
E05
ICD-10 code description
Thyrotoxicosis [hyperthyroidism]
2
Description of health condition studied
anti-thyroid drugs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Neuro-psychologic condition
Timepoint
at the beginning and end of study
Method of measurement
neuro-psychologic tests
2
Description
Development of Goiter
Timepoint
any visit and at the end of study
Method of measurement
physical exam
3
Description
Thyroid function assessment
Timepoint
Every 6 months during follow up and at the end of study
Method of measurement
laboratory
4
Description
Cardiac function
Timepoint
at the end of study
Method of measurement
echocardiography
Secondary outcomes
1
Description
Serum lipid profiles
Timepoint
at the beginning and end of study (during study if needed)
Method of measurement
laboratory
2
Description
bone mineral density
Timepoint
at the end of study
Method of measurement
BMD
3
Description
cost
Timepoint
During follow up and at the end of study
Method of measurement
from actual ambulatory and hospital expenses during follow up
Intervention groups
1
Description
100 µCi iodide 131 per gram of the thyroid In "radioiodine group"
Category
Treatment - Other
2
Description
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.
Category
Treatment - Drugs
3
Description
"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.
Category
Treatment - Drugs
4
Description
"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.