UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052554 |
|---|---|
| Receipt number | R000059960 |
| Scientific Title | Nutritional assessment of breast milk in infants: a cohort study |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2025/04/02 10:11:27 |
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Basic information
Public title
Nutritional assessment of breast milk in infants: a cohort study
Acronym
Nutritional assessment of breast milk in infants: a cohort study
Scientific Title
Nutritional assessment of breast milk in infants: a cohort study
Scientific Title:Acronym
Nutritional assessment of breast milk in infants: a cohort study
Region
| Japan |
Condition
Condition
Healthy mothers and their infants
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate concentrations of various nutrients in Japanese breast milk.
Basic objectives2
Others
Basic objectives -Others
To evaluate associations between concentration of various nutrients in breast milk and the development or growth of infants.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Concetration of various nutrients in Breast milk.
Key secondary outcomes
Associations between various nutriention levels in breast milk and the development and growth of infants.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mother-infant pairs who participated in the "Nutritional evaluation of sn-2 palmitoil lipids in infants: longitudinal observational study" study (the main study), who did not indicate their intention not to participate in future studies, and who do not request to withdraw from participation in the study (maximum 105 pairs).
Key exclusion criteria
Mothers-infant pairs who have indcated not to participate in future studies
Mothers-infant paris who request to withdraw from participation in the study
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Shoji |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
hshoji@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Shoji |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
hshoji@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Shoji Hiromichi
Funding Source
Organization
The Food Science Institute Foundation (Ryoushoku-kenkyukai) (Tokyo, Japan)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The university of Tokyo, Toho university, Meiji Holdings Co., Ltd., Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Juntendo University Hospital
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
jcrtc_operation@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E23-0060
Org. issuing International ID_1
The ethics committee of Juntendo University Hospital
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059960
