UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032673 |
|---|---|
| Receipt number | R000037253 |
| Scientific Title | Nutritional assessment of the arachidonic acid-fortified formula in low-birth-weight infants. |
| Date of disclosure of the study information | 2018/05/22 |
| Last modified on | 2018/05/22 10:23:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Nutritional assessment of the arachidonic acid-fortified formula in low-birth-weight infants.
Acronym
Nutritional assessment of the arachidonic acid-fortified formula in low-birth-weight infants.
Scientific Title
Nutritional assessment of the arachidonic acid-fortified formula in low-birth-weight infants.
Scientific Title:Acronym
Nutritional assessment of the arachidonic acid-fortified formula in low-birth-weight infants.
Region
| Japan |
Condition
Condition
Low birth weight infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety assessment of the arachidonic acid-fortified formula.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatty acid composition of the erythrocyte
membrane.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Arachidonic acid-fortified formula
Interventions/Control_2
Commercially infant formula
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 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects in this study were low-birth-weight infants with a birth weight of 1,000g or higher those whose weight increased to 2,000g or higher at the time of discharge from the NICU.
Key exclusion criteria
Infants with major congenital abnormalities or disorders.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Shoji |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku
TEL
03-3813-3111
hshoji@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Shoji |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-1-1 Hongo, Bunkyo-ku
TEL
03-3813-3111
Homepage URL
hshoji@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nutritional Science Institute, Morinaga
Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 05 | Month | 22 | 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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 22 | Day |
Last modified on
| 2018 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037253
