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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032673
Receipt No. 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

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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
Email 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
Email hshoji@juntendo.ac.jp

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037253

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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