UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042992
Receipt number R000049086
Scientific Title Iodine intake by gargling with mouthwash containing povidone iodine
Date of disclosure of the study information 2021/01/13
Last modified on 2022/10/16 10:52:33

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name