UMIN-CTR Clinical Trial

Basic information
Public title	Iodine intake by gargling with iodine mouthwash
Acronym	Iodine intake from mouthwash
Scientific Title	Iodine intake by gargling with mouthwash containing povidone iodine
Scientific Title:Acronym	Iodine intake from povidone iodine gargling
Region	Japan

Condition
Condition	thyroid dysfunction
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the amount of iodine absorbed by gargling with mouthwash containing povidone iodine
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.The absolute amount and ratio of mouthwash absorbed by gargling 2.The absolute amount and ratio of iodine absorbed by gargling
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	Gargle by standard gargling method with mouthwash containing povidone iodine or distilled water. Measure the amount and ratio of volume and iodine content in the fluid before and after gargling.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Heathy adults
Key exclusion criteria	Denture, oral cavity diseases, dysphagia
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yozen Middle name Last name Fuse
Organization	Foundation for Growth Science
Division name	Research committee on iodine related health problems
Zip code	1130033
Address	5-1-16 Hongo, Bunkyou-ku, Tokyo
TEL	0358055370
Email	fuseyz@hotmai.com

Public contact
Name of contact person	1st name Yozen Middle name Last name Fuse
Organization	Foundation for Growth Science
Division name	Research committee on iodine related health problems
Zip code	1130033
Address	5-1-16 Hongo, Bunkyou-ku, Tokyo
TEL	0358055370
Homepage URL
Email	fuseyz@hotmai.com

Sponsor
Institute	Foundation for Growth Science, Research committee on iodine related health problems
Institute
Department

Funding Source
Organization	Foundation for Growth Science, Research committee on iodine related health problems
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Foundation for Growth Science
Address	Research committee on iodine related health problems
Tel	0358055370
Email	fuseyz@hotmai.com

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	2021 Year 01 Month 13 Day

Related information
URL releasing protocol	https://doi.org/10.1007/s12011-021-02978-7
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1007/s12011-021-02978-7
Number of participants that the trial has enrolled	22
Results	The median and percentage of iodine ingested from gargles were 5.0 mg (range: 2.6-10.8 mg) and 20.5% (range: 10.6-44.5%), respectively. They should be used with caution.
Results date posted	2022 Year 10 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	none
Participant flow	none
Adverse events	none
Outcome measures	iodine intake
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 10 Month 01 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 13 Day
Last modified on	2022 Year 10 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049086