UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	A clinical study to investigate the effect of inactive iodine and lithium carbonate in radioiodine therapy of Graves' disease
Scientific Title	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
Scientific Title:Acronym	A clinical study to investigate the effect of inactive iodine and lithium carbonate in radioiodine therapy of Graves' disease
Region	Japan

Condition
Condition	Graves' disease
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the effect of inactive iodine and lithium carbonate in radioiodine therapy of Graves' disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	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
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Only radioiodine therapy
Interventions/Control_2	Radioiodine therapy and inactive iodine 0.1 mg tid for 5 days
Interventions/Control_3	Radioiodine therapy and lithium carbonate 600 mg tid for 8 days
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	120

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shuhei Nakanishi
Organization	Hiroshima University
Division name	Department of Molecular and Internal Medicine
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL	082-257-5196
Email	atori@hiroshima-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kenji Oki
Organization	Hiroshima University
Division name	Department of Molecular and Internal Medicine
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL	082-257-5196
Homepage URL
Email	kenji-oki@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital Department of Endocrinology and Metabolism
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2008 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2008 Year 01 Month 08 Day
Date of IRB	2008 Year 02 Month 01 Day
Anticipated trial start date	2008 Year 03 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Additional study: The effect of a decrease of the thyroid volume by first time radiation therapy on additional radioiodine therapy

Management information
Registered date	2008 Year 03 Month 19 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001319