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Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients

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ClinicalTrials.gov Identifier: NCT01560299
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : March 22, 2012
Information provided by (Responsible Party):
S.R.ZAKAVI, Mashhad University of Medical Sciences

Brief Summary:

Iodine therapy is the best treatment for graves disease.Most patients receive methimozale prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.

Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and others prefer longer off - methimazole period which bothers most patients. This study aimed to evaluate optimum time for methimazole discontinuation in graves disease.

Condition or disease Intervention/treatment
Graves Disease Drug: Methimazole

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: group one
This group will be advised to discontinue methimazole 24-48 hour before iodine therapy
Drug: Methimazole
Methimazole was stopped 24-48 before radio-iodine therapy
Active Comparator: group two
methimazole stopped 48-72 hour before radioiodine therapy
Drug: Methimazole
methimazole discontinued 49-72 hours before radioiodine treatment
Active Comparator: group three Drug: Methimazole
methimazole discontinued 73-168 hours before radio-iodine treatment

Primary Outcome Measures :
  1. thyroid function tests over one year after radioiodine therapy [ Time Frame: months 1 , 3 ,6,9,12 ]
    thyroid function test may change over one year . In order to consider the patients as cured ,thyroid function tests should reveal hypothyroidism or euthyroidism . In order to rule out temporary hypothyroidism the tests should be repeated after 6 months of radioiodine therapy.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 18-65
  • graves disease(TSH<0.1 &increased FT4 & positive TSI
  • one or more bartlena criteria for radio-iodine therapy
  • 24 hour RAIU>25%
  • euthyroidism after methimazole treatment

Exclusion Criteria:

  • pregnancy or lactation
  • moderate or severe graves ophthalmopathy
  • CHF or coronary heart disease
  • palpable thyroid nodule
  • lithium or amiodarone or lugol or ipodate treatment
  • recent imaging with contrast agent
  • very large goiter(more than 150 gram)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560299

Iran, Islamic Republic of
Mashad University of Medical Sciences
Mashad, Khorasan Razavi, Iran, Islamic Republic of, 91766
Sponsors and Collaborators
Mashhad University of Medical Sciences
Principal Investigator: rasoul zakavi, associate professor Mashhad University of Medical Sciences

Responsible Party: S.R.ZAKAVI, associate professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01560299     History of Changes
Other Study ID Numbers: Metiodine
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by S.R.ZAKAVI, Mashhad University of Medical Sciences:
graves disease

Additional relevant MeSH terms:
Graves Disease
Orbital Diseases
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs