UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054831 |
|---|---|
| Receipt number | R000062621 |
| Scientific Title | Research on the development of a service that easily determines a child's nutritional status from urine |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/01/06 11:56:48 |
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Basic information
Public title
Research on the development of a service that easily determines a child's nutritional status from urine
Acronym
Research on the development of a service that easily determines a child's nutritional status from urine
Scientific Title
Research on the development of a service that easily determines a child's nutritional status from urine
Scientific Title:Acronym
Research on the development of a service that easily determines a child's nutritional status from urine
Region
| Japan |
Condition
Condition
Healthy infant
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to develop a service that can easily determine a child's nutritional status from their urine by conducting a urine test to determine whether children have taken nutritional supplements or not, as well as a questionnaire survey regarding their lifestyle habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calcium, iron, folic acid, zinc, and creatinine levels in urine before and after consuming the test food for 1 month. The test foods were UHA Gummy Supplement KIDS from UHA Mikakuto (Mikakuto Group) and Ayo-1 from Nutribase LLC.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume the manufacturer's recommended amount of UHA gummy supplement KIDS from UHA Mikakuto (Mikakuto group) or Ayo-1 from Nutribase LLC for one month.
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Kansai Electric Power Company's "Happy e-Miruden" member
Those who live in Shiga prefecture, Kyoto prefecture, Osaka prefecture, Nara prefecture, Wakayama prefecture, Hyogo prefecture (excluding some parts), part of Fukui prefecture, part of Gifu prefecture, and part of Mie prefecture.
If your child is between 4 and 6 years old and you are not concerned about their health, but you are concerned about their nutritional status.
Those who are able to undergo two tests and take supplementary foods for about a month (it is preferable to take supplementary foods every day, but this does not mean that you cannot take them on some days)
Those who can respond to questionnaires regarding the effects of food intake and food intake status during the food intake period.
Those who are able to respond to questionnaires and respond to interviews after all periods have ended (interviews are optional)
Key exclusion criteria
People with allergies or illnesses
People suffering from certain chronic diseases such as diabetes, hypertension, and hyperlipidemia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | Hagiwara |
Organization
Yuurea Co., Ltd.
Division name
Research director
Zip code
451-0000
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
TEL
080-5055-3551
hagiwara.keitaro@yuurea.co.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Hagiwara |
Organization
Yuurea Co., Ltd.
Division name
Research director
Zip code
451-0000
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
TEL
080-5055-3551
Homepage URL
hagiwara.keitaro@yuurea.co.jp
Sponsor or person
Institute
Yuurea Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
The Kansai Electric Power Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
Tel
080-5055-3551
hagiwara.keitaro@yuurea.co.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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062621
