Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedMarch 22, 2012
March 1, 2012
1.9 years
March 1, 2012
March 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
months 1 , 3 ,6,9,12
Study Arms (3)
group one
ACTIVE COMPARATORThis group will be advised to discontinue methimazole 24-48 hour before iodine therapy
group two
ACTIVE COMPARATORmethimazole stopped 48-72 hour before radioiodine therapy
group three
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age 18-65
- graves disease(TSH\<0.1 \&increased FT4 \& positive TSI
- one or more bartlena criteria for radio-iodine therapy
- hour RAIU\>25%
- euthyroidism after methimazole treatment
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mashad University of Medical Sciences
Mashhad, Khorasan Razavi, 91766, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
rasoul zakavi, associate professor
Mashhad University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
March 1, 2012
First Posted
March 22, 2012
Study Start
February 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
March 22, 2012
Record last verified: 2012-03