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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043770
Receipt No. R000049964
Scientific Title The effect of povidone iodine (PVP-I) on thyroid function. Preliminary Study: Iodine intake from iodine mouthwash by gargling.
Date of disclosure of the study information 2021/03/29
Last modified on 2021/10/21

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Basic information
Public title The effect of oral disinfectant containing iodine on thyroid function. Preliminary Study: Iodine intake from mouthwash and antiseptic solution.
Acronym The effect of iodine intake from mouthwash and antiseptic spray on thyroid function.
Scientific Title The effect of povidone iodine (PVP-I) on thyroid function. Preliminary Study: Iodine intake from iodine mouthwash by gargling.
Scientific Title:Acronym Iodine intake from PVP-I gargling or spraying.
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 effect of oral disinfectant containing povidone iodine on thyroid function. As a preliminary study the amount of iodine absorbed by gargling or spraying with mouthwash containing povidone iodine is determined.
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 standardized 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
Interventions/Control_1 Gargle by standarized method with mouthwash containing PVP-I 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 Research committee on iodine related health problems, Foundation for Growth Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Japanese Red Cross Hokkaido College of Nursing
Address 664-1 Asahicho, Kitami City, Hokkaido
Tel 0157-66-3311
Email yito@rchokkaido-cn.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
2021 Year 03 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications DOI : 10.1007/s12011-021-02978-7
Number of participants that the trial has enrolled 22
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 Completed
Date of protocol fixation
2020 Year 12 Month 01 Day
Date of IRB
2021 Year 02 Month 25 Day
Anticipated trial start date
2021 Year 02 Month 26 Day
Last follow-up date
2022 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 03 Month 28 Day
Last modified on
2021 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049964

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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