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

March 20, 2012 updated by: S.R.ZAKAVI, Mashhad University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Mashad, Khorasan Razavi, Iran, Islamic Republic of, 91766
        • Mashad University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: Methimazole
methimazole discontinued 49-72 hours before radioiodine treatment
Drug: Methimazole
methimazole discontinued 73-168 hours before radio-iodine treatment
Active Comparator: group two
methimazole stopped 48-72 hour before radioiodine therapy
Drug: Methimazole
Methimazole was stopped 24-48 before radio-iodine therapy
Drug: Methimazole
methimazole discontinued 49-72 hours before radioiodine treatment
Drug: Methimazole
methimazole discontinued 73-168 hours before radio-iodine treatment
Active Comparator: group three
Drug: Methimazole
Methimazole was stopped 24-48 before radio-iodine therapy
Drug: Methimazole
methimazole discontinued 49-72 hours before radioiodine treatment
Drug: Methimazole
methimazole discontinued 73-168 hours before radio-iodine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
months 1 , 3 ,6,9,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metiodine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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