UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039138 |
|---|---|
| Receipt number | R000044639 |
| Scientific Title | Nationwide Survey on Iodine Intake in Japan |
| Date of disclosure of the study information | 2020/01/14 |
| Last modified on | 2024/04/17 19:51:06 |
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Basic information
Public title
Nationwide Survey on Iodine Intake in Japan
Acronym
IIS
Scientific Title
Nationwide Survey on Iodine Intake in Japan
Scientific Title:Acronym
NWSII
Region
| Japan |
Condition
Condition
Iodine nutrition
Classification by specialty
| Endocrinology and Metabolism | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the iodine nutritional status in Japan
Basic objectives2
Others
Basic objectives -Others
In 47 prefectures nationwide, 1. To measure urinary iodine concentration in children aged 6 to 12 years old, and 2. iodine intake in their guardian assessed by diet study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary iodine concentration in children
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children
Key exclusion criteria
Children with past and present history of thyroid disease
Target sample size
50000
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
03-5805-5370
fuseyz@hotmail.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
03-5805-5370
Homepage URL
fuseyz@hotmail.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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Clinical Medicine, Japanese Red Cross Hokkaido College of Nursing
Address
664-1, Akebonochou, Kitami, 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
公益財団法人成長科学協会（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Main results already published
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In 47 prefectures of Japan urinary iodine concentration of schoo-aged children and iodine intake of their guardians were assessed by using a WHO method.
Management information
Registered date
| 2020 | Year | 01 | Month | 13 | 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=R000044639
