UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043170 |
|---|---|
| Receipt number | R000049269 |
| Scientific Title | Study on iodine excretion in Japanese young women |
| Date of disclosure of the study information | 2021/01/30 |
| Last modified on | 2021/01/29 00:15:43 |
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Basic information
Public title
Study on iodine excretion in Japanese young women
Acronym
Study on iodine excretion in Japanese young women
Scientific Title
Study on iodine excretion in Japanese young women
Scientific Title:Acronym
Study on iodine excretion in Japanese young women
Region
| Japan |
Condition
Condition
young women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is basic study on iodine excretion in Japanese women.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary iodine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of kelp (arbitrary amount)
Interventions/Control_2
Simple iodine restriction (restriction on foods high in iodine such as seaweed other than the 3-day test food)
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Female
Key inclusion criteria
Those who are relatively healthy and have no plans to become pregnant
Key exclusion criteria
People with chronic illness/pregnant woman/breast-feeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Toubou |
Organization
Shokei university (Old affiliation)
Division name
Faculty of Life Sciences
Zip code
862-8678
Address
2-6-78, Kuhonji, Chuo-ku, Kumamoto, Japan
TEL
096-362-2011
htoubou@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Toubou |
Organization
Shinshu university
Division name
School of medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL
0263-37-2622
Homepage URL
htoubou@shinshu-u.ac.jp
Sponsor or person
Institute
Shokei university
Institute
Department
Personal name
Funding Source
Organization
shokei university
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
Shokei university
Address
2-6-78, Kuhonji, Chuo-ku, Kumamoto, Japan
Tel
096-362-2011
sakata@shokei-gakuen.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 | 01 | Month | 30 | Day |
Related information
URL releasing protocol
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201602247834287628
Publication of results
Partially published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201602247834287628
Number of participants that the trial has enrolled
36
Results
After iodine restriction, the amount of urinary iodine was about 80 ug/g-cre. After loading kelp equivalent to 2600 ug of iodine, about 80% of the intake was excreted.
Results date posted
| 2021 | Year | 01 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
After acquiring the additional data, the analysis was delayed due to the transfer.
Date of the first journal publication of results
| 2016 | Year | 10 | Month | 05 | Day |
Baseline Characteristics
young women
Participant flow
After explaining the study, written consent was obtained. After refraining from ingesting designated foods for 3 days, they ate kelp. Urine was collected after ingestion.
Adverse events
none
Outcome measures
urinary iodine
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049269
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
