Back to resultsEvaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
Primary Purpose
Graves Disease
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Methimazole
Methimazole
Methimazole
Sponsored by
About this trial
This is an interventional treatment trial for Graves Disease focused on measuring hyperthyroidism, radio-iodine, I-131, methimazole, graves disease
Eligibility Criteria
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)
Sites / Locations
- Mashad University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
group one
group two
group three
Arm Description
This group will be advised to discontinue methimazole 24-48 hour before iodine therapy
methimazole stopped 48-72 hour before radioiodine therapy
Outcomes
Primary Outcome Measures
thyroid function tests over one year after radioiodine therapy
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01560299
First Posted
March 1, 2012
Last Updated
March 20, 2012
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01560299
Brief Title
Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease
Keywords
hyperthyroidism, radio-iodine, I-131, methimazole, graves disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group one
Arm Type
Active Comparator
Arm Description
This group will be advised to discontinue methimazole 24-48 hour before iodine therapy
Arm Title
group two
Arm Type
Active Comparator
Arm Description
methimazole stopped 48-72 hour before radioiodine therapy
Arm Title
group three
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Methimazole
Intervention Description
Methimazole was stopped 24-48 before radio-iodine therapy
Intervention Type
Drug
Intervention Name(s)
Methimazole
Intervention Description
methimazole discontinued 49-72 hours before radioiodine treatment
Intervention Type
Drug
Intervention Name(s)
Methimazole
Intervention Description
methimazole discontinued 73-168 hours before radio-iodine treatment
Primary Outcome Measure Information:
Title
thyroid function tests over one year after radioiodine therapy
Description
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.
Time Frame
months 1 , 3 ,6,9,12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rasoul zakavi, associate professor
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashad University of Medical Sciences
City
Mashad
State/Province
Khorasan Razavi
ZIP/Postal Code
91766
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
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