UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025088
Receipt number R000028830
Scientific Title Biotin supplement for very low birth weight infant
Date of disclosure of the study information 2017/01/01
Last modified on 2019/10/16 16:54:04

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Basic information

Public title

Biotin supplement for very low birth weight infant

Acronym

Biotin for very low birth weight infant

Scientific Title

Biotin supplement for very low birth weight infant

Scientific Title:Acronym

Biotin for very low birth weight infant

Region

Japan


Condition

Condition

very low birth weight infant

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine whether biotin supplementation is effective for late onset metabolic acidosis of very low birth weight infant.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

late onset metabolic acidosis for 3-8 weeks of age

Key secondary outcomes

mortality at discharge
neurological morbidity at the age of two years


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

oral supplementation of biotin 0.5mg once a day from the third day of life to the day of discharge

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 days-old <

Age-upper limit

7 days-old >

Gender

Male and Female

Key inclusion criteria

very low birth weight infants born at our hospital

Key exclusion criteria

congenital malformation syndrome
abnormalities of chromosome

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Shoji
Middle name
Last name Kagami

Organization

Tokushima University Hospital

Division name

Pediatrics

Zip code

7708503

Address

Kuramoto-cho 2chome , Tokushima

TEL

+81-88-633-9555

Email

kagami@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Suga

Organization

Tokushima University Hospital

Division name

Pediatrics

Zip code

7708503

Address

Kuramoto-cho 2chome , Tokushima

TEL

+81-88-633-9555

Homepage URL


Email

suga.kenichi.1@tokushima-u.ac.jp


Sponsor or person

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name



Funding Source

Organization

Research funding of Morinaga

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

Clinical trial center for developmental therapeutics of Tokushima University

Address

Kuramoto-cho 2chome , Tokushima

Tel

088-633-9294

Email

awachiken@tokushima-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

2017 Year 01 Month 01 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

2016 Year 12 Month 26 Day

Date of IRB

2016 Year 12 Month 26 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2019 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028830


Research Plan
Registered date File name
2017/11/30 ビオチン投与 研究計画 .pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name