UMIN-CTR Clinical Trial

Public title

Evaluation of the efficacy of potassium iodide preparation for radioactive iodine therapy in Graves' disease

Acronym

Evaluation of the efficacy of potassium iodide preparation for radioactive iodine therapy in Graves' disease

Scientific Title

Evaluation of the efficacy of potassium iodide preparation for radioactive iodine therapy in Graves' disease

Scientific Title:Acronym

Evaluation of the efficacy of potassium iodide preparation for radioactive iodine therapy in Graves' disease

Region

Japan

Condition

Graves' disease

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Seigo Tachibana

Organization

Yamashita thyroid and parathyroid clinic

Division name

Endocrinology

Zip code

Address

1-8 Shimogofukumachi, Hakata-ku, Fukuoka City 812-0034, Japan

TEL

092-281-1300

Email

sei.tac.thyroid@gmail.com

Name of contact person

1st name
Middle name
Last name	Seigo Tachibana

Organization

Yamashita thyroid and parathyroid clinic

Division name

Endocrinology

Zip code

Address

1-8 Shimogofukumachi, Hakata-ku, Fukuoka City 812-0034, Japan

TEL

092-281-1300

Homepage URL

Email

sei.tac.thyroid@gmail.com

Institute

Yamashita thyroid and parathyroid clinic

Institute

Department

Personal name

Organization

Yamashita thyroid and parathyroid clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人福甲会やましたクリニック（福岡県）

Date of disclosure of the study information

2016

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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.

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

05

Month

01

Day

Date of IRB

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

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.

Registered date

2016

Year

11

Month

18

Day

Last modified on

2016

Year

11

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028646