UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035422 |
|---|---|
| Receipt number | R000040356 |
| Scientific Title | Intravenous administration of selenium for intenstinal failure patients |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2024/04/16 15:09:00 |
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Basic information
Public title
Intravenous administration of selenium for intenstinal failure patients
Acronym
Intravenous administration of selenium
Scientific Title
Intravenous administration of selenium for intenstinal failure patients
Scientific Title:Acronym
Intravenous administration of selenium
Region
| Japan |
Condition
Condition
Intestinal failure patients
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of selenium in intestinal failure patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will check blood test 2 times per year.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We will administer selenium, which is 1~1.5 micro-g/kg/day, by intravenous everyday.
We will check blood test 2 times per year.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients whose need parenteral nutrition for a long time.
Key exclusion criteria
The patients have allergy for selenium.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kinoshita |
Organization
Niigata University dental and medical hospital
Division name
Pediatric Surgery
Zip code
9518510
Address
Asahi-machi 1-754, Chuo-ku, Niigata, Japan
TEL
025-227-2258
kubotama@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuhki |
| Middle name | |
| Last name | Arai |
Organization
Niigata University Dental and Medical Hospital
Division name
Pediatric Surgery
Zip code
9518510
Address
Asahi-machi 1-754, Chuo-ku, Niigata, Japan
TEL
025-227-2258
Homepage URL
arai@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Dental and Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Niigata University Dental and Medical Hospital
Address
Asahi-machi 1-754, Chuo-ku, Niigata, Japan
Tel
025-227-2258
pedsurg@med.niigata-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
| 2019 | 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 | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040356
