UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042816 |
|---|---|
| Receipt number | R000048872 |
| Scientific Title | An exploratory study of fatty acid composition in children |
| Date of disclosure of the study information | 2020/12/24 |
| Last modified on | 2024/04/10 15:03:33 |
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Basic information
Public title
An exploratory study of fatty acid composition in children
Acronym
An exploratory study of fatty acid composition
Scientific Title
An exploratory study of fatty acid composition in children
Scientific Title:Acronym
An exploratory study of fatty acid composition
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis the fatty acid fraction in healthy children
Basic objectives2
Others
Basic objectives -Others
Evaluation of standard value
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The fatty acid fraction in healthy children
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 3 | months-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy child
Key exclusion criteria
Patients who have difficulty ingesting
Patients with metabolic disorders
Patients with liver disease
Patients with gastrointestinal disorders
Patients with a history of parenteral nutrition
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | TAJIRI |
| Middle name | |
| Last name | TATSURO |
Organization
Kyushu University Hospital
Division name
Department of Pediatric Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL
0926425573
tajiri.tatsuro.909@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | ATSUHISA |
| Middle name | |
| Last name | FUKUTA |
Organization
Kyushu University Hospital
Division name
Department of Pediatric Surgery
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL
0926425573
Homepage URL
m02074af@pedsurg.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Pediatric Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory
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
Kyushu University Center for Clinical Translational Research
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-city
Tel
092-642-5774
bynintei@jimu.kyushu-u.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
| 2020 | Year | 12 | Month | 24 | 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
141
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
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure fatty acid fractions for 210 healthy children and analysis the growth curve of fatty acid fractions in childhood.
Management information
Registered date
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048872
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
