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
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
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
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
