UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043770 |
|---|---|
| Receipt number | 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 | 2024/04/17 20:03:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
fuseyz@hotmai.com
Sponsor or person
Institute
Research committee on iodine related health problems, Foundation for Growth Science
Institute
Department
Personal name
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
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
DOI : 10.1007/s12011-021-02978-7
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
Around 5 mg of iodine could theoretically enter the body with one gargle which exceeds the tolerable upper intake level of iodine for adults.
Results date posted
| 2024 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy aduts without thyroid disease
Participant flow
none
Adverse events
none
Outcome measures
Iodine content absorbed into the body
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
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049964
