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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

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 - A clinical study to investigate the effect of inactive iodine and lithium carbonate in radioiodine therapy of Graves' disease

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001087
Enrollment
120
Registered
2008-03-19
Start date
2008-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves&#39

Interventions

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

Sponsors

Hiroshima University Hospital Department of Endocrinology and Metabolism
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Graves' disease according to the guideline of the Japan Thyroid Association Patient who hoped for radioiodine treatment after enough explanation about risk and benefit of this therapy. Age>=19 years old when the consent is obtained. Possible to attend a hospital regularly about 24 weeks. No previous radioiodine therapy. Possible to obtain written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKenji Oki

Hiroshima University Department of Molecular and Internal Medicine

kenji-oki@hiroshima-u.ac.jp082-257-5196

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026