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

UMIN ID: UMIN000001087

Registered date:19/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Graves' disease
• Date of first enrollment: 2008/03/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Only radioiodine therapy
Radioiodine therapy and inactive iodine 0.1 mg tid for 5 days
Radioiodine therapy and lithium carbonate 600 mg tid for 8 days

Outcome(s)

• Primary Outcome: 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: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Hiroshima University Hospital Department of Endocrinology and Metabolism
• Secondary Sponsor: None
• Source(s) of Monetary Support: None,None