UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy of potassium iodide preparation for radioactive iodine therapy in Graves' disease
Title of the study (Brief title)	Evaluation of the efficacy of potassium iodide preparation for radioactive iodine therapy in Graves' disease
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to evaluate the efficacy of potassium iodide (KI) preparation for radioactive iodine therapy (RAIT) in Graves' disease (GD) and whether a short-term discontinuation of KI before RAIT is a safe and useful method in GD patients exhibiting adverse effects from antithyroid drugs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	variation of FT4 between before and at 4 days after discontinuation of methimazole (MMI) or KI between KI prepariton group and MMI preparation group
Key secondary outcomes	Radioactive iodine uptake before RAIT, thyroid gland weight, dose of administered 131-I, dose of 131-I based on thyroid gland weight, free thyroxine (FT4) at RAIT, thyroid function at one year after RAIT and thyroid gland weight at one year after RAIT between above two gruops

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The inclusion criteria was defined as follows; more than 18 years old at RAIT.
Key exclusion criteria	The exclusion criteria was defined as follows; large goiter and/or experience of previous RAIT. The definition of large goiter in exclusion criteria was determined that estimated thyroid gland weight was more than 50 g.
Target sample size	24

Research contact person
Name of lead principal investigator	Seigo Tachibana
Organization	Yamashita thyroid and parathyroid clinic
Division name	Endocrinology
Address	1-8 Shimogofukumachi, Hakata-ku, Fukuoka City 812-0034, Japan
TEL	092-281-1300
Email	sei.tac.thyroid@gmail.com

Public contact
Name of contact person	Seigo Tachibana
Organization	Yamashita thyroid and parathyroid clinic
Division name	Endocrinology
Address	1-8 Shimogofukumachi, Hakata-ku, Fukuoka City 812-0034, Japan
TEL	092-281-1300
Homepage URL
Email	sei.tac.thyroid@gmail.com

Sponsor
Institute	Yamashita thyroid and parathyroid clinic
Institute
Department

Funding Source
Organization	Yamashita thyroid and parathyroid clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	医療法人福甲会やましたクリニック（福岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 01 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	RAIU before RAIT (p=0.0018), dose of 131-I (p=0.0037), FT4 at RAIT (p=0.0034), and thyroid gland weight one year after RAIT (p=0.0065) showed significant differences. Thyroid gland weight, dose of 131-I based on thyroid gland weight, difference in FT4 between before drug discontinuation and at RAIT, and thyroid function at one year after RAIT did not show any significant differences. These results suggest that most patients without large goiter and/or highly aggressive disease may be safely and efficiently treated with RAIT and KI pretreatment until 4 days before therapy.
Other related information	This is a retrospective chart review. The 24 patients enrolled in this study were divided into two groups. Before RAIT, 11 patients were administered KI and were referred to as the KI group. The remaining 13 patients were administered methimazole (MMI) and referred to as the MMI group. Between these two groups, the following factors were compared; RAIU (radioactive iodine uptake) before RAIT, thyroid gland weight, dose of administered 131-I, dose of 131-I based on thyroid gland weight, free thyroxine (FT4) at RAIT, difference in FT4 between before and 4 days after discontinuation of drugs, and thyroid function and thyroid gland weight one year after RAIT.

Management information
Registered date	2016 Year 11 Month 18 Day
Last modified on	2016 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028646