UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047160 |
|---|---|
| Receipt number | R000053788 |
| Scientific Title | An observational study to investigate functional ingredients in breast milk for child growth and development |
| Date of disclosure of the study information | 2022/03/14 |
| Last modified on | 2023/09/20 15:05:37 |
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Basic information
Public title
Exploring functional ingredients in breast milk for child growth and development
Acronym
Functional ingredients in breast milk for child growth and development
Scientific Title
An observational study to investigate functional ingredients in breast milk for child growth and development
Scientific Title:Acronym
Observational study of functional ingredients in breast milk for child growth and development
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to explore new functional ingredients in breast milk which may relate to appropriate weight gain, bone density and neurodevelopment of children, targeting mother-child pairs selected by physical and health condition and nutrition and so on.
Basic objectives2
Others
Basic objectives -Others
Association between functional ingredients in breast milk and child growth/development
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Child obesity/overweight, bone density, neurodevelopment
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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Fathers participate to the BirThree Cohort Study
(2) Children are breastfed by the first month of life
(3) Breast milk is collected at the first month of life
(4) Children take health checkup by the municipalities
(5) Children take follow-up survey at the Community Support Centers of the Tohoku Medical Megabank Organization
Based on the above criteria, children, fathers and mothers whose data of basic characteristics (sex, age, relationship), questionnaire, follow-up survey at the Community Support Centers of the Tohoku Medical Megabank Organization, maternal and child health handbook, health checkup by the municipalities, medical record and breast milk are fully available
Key exclusion criteria
People whose consents are withdrawn before the study begins
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Obara |
Organization
Tohoku University
Division name
Department of Preventive Medicine and Epidemiology, Tohoku Medical Megabank Organization
Zip code
980-8573
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-8104
obara-t@megabank.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Obara |
Organization
Tohoku University
Division name
Birth and Three-Generation Cohort Study, Tohoku Medical Megabank Organization
Zip code
980-8573
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-8104
Homepage URL
obara-t@megabank.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ToMMo REC
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-3965
tommo-ken@grp.tohoku.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
| 2022 | Year | 03 | 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
184
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association between functional ingredients in breast milk and child growth/development will be investigated.
Management information
Registered date
| 2022 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053788
