UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049469 |
|---|---|
| Receipt number | R000056318 |
| Scientific Title | A study on the actual intake of iron in children |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/07 16:55:11 |
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Basic information
Public title
A study on the actual intake of iron in children ("Project of iron status assessment")
Acronym
A study on the actual intake of iron in children ("Project of iron status assessment")
Scientific Title
A study on the actual intake of iron in children
Scientific Title:Acronym
A study on the actual intake of iron in children
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain the data of blood hemoglobin concentration measured in the project "Project of iron status assessment" implemented by Meiji Co., Ltd., and grasp the actual situation of anemia in children in Japan.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of children aged 1-6 years below the WHO blood hemoglobin cut-off value
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children (1-6 years old) who participated in the project "Project of iron status assessment" and had their blood hemoglobin levels measured.
2. Children whose mothers understand the purpose and content of this research and do not refuse to participate in this research as children's legally acceptable representative.
Key exclusion criteria
Children who have previously participated in this study
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Chiharu |
| Middle name | |
| Last name | Tsutsumi |
Organization
Sagami Women's University
Division name
Faculty of Nutritional Science
Zip code
252-0383
Address
2-1-1 Bunkyo, Minami-ku Sagamihara, Kanagawa
TEL
042-742-2013
c-tsutsumi@star.sagami-wu.ac.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Tsutsumi |
Organization
Sagami Women's University
Division name
Faculty of Nutritional Science
Zip code
252-0383
Address
2-1-1 Bunkyo, Minami-ku Sagamihara, Kanagawa
TEL
042-742-2013
Homepage URL
c-tsutsumi@star.sagami-wu.ac.jp
Sponsor or person
Institute
Sagami Women's University
Institute
Department
Personal name
Funding Source
Organization
The Food Science Institute Foundation (Ryoushoku-kenkyukai)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Sagami Women's University
Address
2-1-1 Bunkyo, Minami-ku Sagamihara, Kanagawa
Tel
042-742-2013
c-tsutsumi@star.sagami-wu.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
| 2024 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of the relationship between blood hemoglobin concentration data and questionnaire survey results.
Management information
Registered date
| 2022 | Year | 11 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056318
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
