UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039145 |
|---|---|
| Receipt number | R000044645 |
| Scientific Title | Variation of iodine intake in Japanese |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2022/10/16 10:59:00 |
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Basic information
Public title
Variation of iodine intake in Japanese
Acronym
IIS
Scientific Title
Variation of iodine intake in Japanese
Scientific Title:Acronym
VIIS
Region
| Japan |
Condition
Condition
Thyroid disease
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify iodine metabolism and variability of iodine intake in Japanese
Basic objectives2
Others
Basic objectives -Others
To measure iodine intake for 10 consecutive days in each 4 seasons
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intra- and inter-individual variation of iodine intake
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
subjects with the past and present history of thyroid disease
Target sample size
80
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
Research committee on iodine related health problems
Foundation for Growth Science
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
Kamakura Women's University
Address
6-1-3 Ofuna, Kamakura
Tel
0467442111
newfacenobu@gmail.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
| 2020 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ21-0486/_article/-char/en
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ21-0486/_article/-char/en
Number of participants that the trial has enrolled
24
Results
There was a high fluctuation in the UIE and DII in the university students. The intra- and inter- individual crude coefficients of variation were 123 or 294.7% for UIE, and 58.3 or 88.7% for DII, respectively, indicating a higher variance of habitual iodine intake than in other countries. The frequency of occurrence for UIE above 3 mg was every 43 days.
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
urinary iodine concentration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation on variation of urinary iodine excretion in healthy adults
Management information
Registered date
| 2020 | Year | 01 | Month | 14 | 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=R000044645
| 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 |
