UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010441
Receipt number R000012209
Scientific Title Nutritional assessment of the biotin-fortified formula with reduced protein content.
Date of disclosure of the study information 2013/04/08
Last modified on 2019/10/13 09:32:50

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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 developmental 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

2 weeks-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Singleton, term infants (gestational age; >37.0,<41.0 weeks) who were born at Juntendo 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 Hiromichi
Middle name
Last name Shoji

Organization

Juntendo University Faculty of Medicine

Division name

Department of Pediatrics

Zip code

113-8421

Address

Tokyo

TEL

+81338133111

Email

hshoji@juntendo.ac.jp


Public contact

Name of contact person

1st name Hiromichi
Middle name
Last name Shoji

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code

113-8421

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

+81338133111

Homepage URL


Email

hshoji@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Faculty of Medicine

Institute

Department

Personal name



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

Juntendo University Faculty of Medicine

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

Tel

03-3813-3111

Email

chiken@juntendo.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

2013 Year 04 Month 08 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

47

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

2013 Year 03 Month 01 Day

Date of IRB

2014 Year 03 Month 22 Day

Anticipated trial start date

2014 Year 05 Month 01 Day

Last follow-up date

2018 Year 10 Month 31 Day

Date of closure to data entry

2018 Year 10 Month 31 Day

Date trial data considered complete

2018 Year 10 Month 31 Day

Date analysis concluded

2018 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 04 Month 08 Day

Last modified on

2019 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012209


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name