A randomized open-labelled controlled prospective study to investigate the effect of inactive iodine and lithium carbonate on radioiodine therapy in patients with Graves' disease
Phase 3
Completed
- Conditions
- Graves'disease
- Registration Number
- JPRN-UMIN000001087
- Lead Sponsor
- Hiroshima University Hospital Department of Endocrinology and Metabolism
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
Pregnancy, suspected pregnancy or who won't avoid pregnancy within one year. Nursing woman (possible when not nursing). Active Graves' ophthalmopathy (CAS ) or deterioration in eye symptoms in the preceding months Contraindication of inactive iodine and lithium carbonate. Any other reason for which the investigator judged the patient to be unfit for study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who achieved an euthyroid or hypothyroid at 24 weeks after radioiodine therapy : free T4 level of less than upper limit of normal
- Secondary Outcome Measures
Name Time Method Proportion of patients who achieved an euthyroid or hypothyroid at 24 weeks after radioiodine therapy : free T3 level of less than upper limit of normal and TSH level of more than lower limit of normal. Changes in thyroid volume from 0 to 1 and 24 weeks. Incidence and evaluation of adverse events