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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014295
Receipt No. R000016648
Scientific Title Nutritional assessment of the biotin-fortified formula with reduced protein content.
Date of disclosure of the study information 2014/06/18
Last modified on 2014/06/18

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Basic information
Public title Nutritional assessment of the biotin-fortified formula with reduced protein content.
Acronym Nutritional assessment of the biotin-fortified formula with reduced protein content.
Scientific Title Nutritional assessment of the biotin-fortified formula with reduced protein content.
Scientific Title:Acronym Nutritional assessment of the biotin-fortified formula with reduced protein content.
Region
Japan

Condition
Condition Normal infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 safety assessment of the biotin-fortified formula with reduced protein content.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Growth and development outcome of the infants
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 The biotin-fortified formula with reduced protein content.
Interventions/Control_2 Commercially infant formula with reduced protein content
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
0 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Singleton, term infants (gestational age>36, <42 weeks) who were born at The University of Tokyo Hospital
Key exclusion criteria Infants with major congenital abnormalities or disorders
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Takahashi
Organization The University of Tokyo Hospital
Division name Department of Maternal, Fetal and Neonatal Medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 81-3-5800-8659
Email tnaoto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Takahashi
Organization The University of Tokyo Hospital
Division name Department of Maternal, Fetal and Neonatal Medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-8659
Homepage URL
Email tnaoto-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Faculty of Medicine
Institute
Department

Funding Source
Organization The Food Science Institute Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 06 Month 18 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 Open public recruiting
Date of protocol fixation
2014 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 18 Day
Last modified on
2014 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016648

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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