UMIN-CTR Clinical Trial

Basic information
Public title	The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Acronym	The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Scientific Title	The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Scientific Title:Acronym	The influence of therapeutic inorganic iodine for Graves' disease on long-term prognosis.
Region	Japan

Condition
Condition	Graves' disease
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Research for recurrence rate of Graves' hyperthyroidism during and after discontinuation of inorganic iodine treatment
Basic objectives2	Others
Basic objectives -Others	Analysis of factors related to the recurrence of Graves' hyperthyroidism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence rate of Graves' hyperthyroidism during and after discontinuation of inorganic iodine treatment
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) A patient's age at the registration of present study is 20< and <85 years old. (2) A patient with Graves' disease treated only with inorganic iodine (3) Therapeutic dose is less than 25 mg/day as potassium iodine. (4) Thyroid function maintain normal range (>1.0 microIU/mL) at recently more than 2 times. (5) Serum TSH receptor antibody measured by M22 antibody based assay is <10 IU/L. Fulfill the criteria (2)-(5) for more than 6 months before registration. (6) A patient who agrees with the informed consent of present study.
Key exclusion criteria	(1) A patient is treated with anti-thyroid drugs except inorganic iodine. (2) A patient is not pregnant woman or lactating woman or expected pregnancy within recent 2 years. (3) A patient has uncontrolled Graves' disease or untreated heart disease. (4) A patient has already treated with radioiodine or surgery. (5) A patient is inappropriate for present study by judging from the manager of the study.
Target sample size	66

Research contact person
Name of lead principal investigator	1st name Uchida Middle name Last name Toyoyoshi
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism & Endocrinology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL	03-5802-1579
Email	uchitoyo@juntendo.ac.jp

Public contact
Name of contact person	1st name Uchida Middle name Last name Toyoyoshi
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism & Endocrinology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo, Tokyo, Japan
TEL	03-5802-1579
Homepage URL
Email	uchitoyo@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	ethics committee of Juntendo University Hospital
Address	2-1-1 Hongo, Bunkyo, Tokyo, Japan
Tel	03-3813-3111
Email	uchitoyo@juntendo.ac.jp

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

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 01 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	56
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	No longer recruiting
Date of protocol fixation	2018 Year 11 Month 14 Day
Date of IRB	2018 Year 12 Month 28 Day
Anticipated trial start date	2018 Year 12 Month 28 Day
Last follow-up date	2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	After making decision of treatment for patients with Graves' disease treated with inorganic iodine, the patients is observed at the out-patient clinic for two years.

Management information
Registered date	2022 Year 05 Month 06 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054301