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

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01560299
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 23
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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	Phase
Graves Disease	Drug: Methimazole; Drug: Methimazole; Drug: Methimazole	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. thyroid function tests over one year after radioiodine therapy [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mashad University of Medical Sciences	Mashad	Khorasan Razavi	Iran, Islamic Republic of	91766

Sponsors and Collaborators

• Mashhad University of Medical Sciences

Investigators

• Principal Investigator: rasoul zakavi, associate professor, Mashhad University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: S.R.ZAKAVI, associate professor, Mashhad University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01560299
• Other Study ID Numbers: Metiodine
• First Posted: Mar 22, 2012
• Last Update Posted: Mar 22, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by S.R.ZAKAVI, associate professor, Mashhad University of Medical Sciences: hyperthyroidism; radio-iodine; I-131; methimazole; graves disease
• Additional relevant MeSH terms: Graves Disease; Methimazole

Study Results

No Results Posted as of Mar 22, 2012