UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027883 |
|---|---|
| Receipt number | R000031948 |
| Scientific Title | Clinical trial of sodium selenite in patient with selenium deficiency |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/03/29 15:47:24 |
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Basic information
Public title
Clinical trial of sodium selenite in patient with selenium deficiency
Acronym
Clinical trial of sodium selenite for selenium deficiency
Scientific Title
Clinical trial of sodium selenite in patient with selenium deficiency
Scientific Title:Acronym
Clinical trial of sodium selenite for selenium deficiency
Region
| Japan |
Condition
Condition
selenium deficiency
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
selenium supplementation in patient with selenium deficiency
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of visual and sensory disturbance at 4 weeks after sodium selenite was started
Key secondary outcomes
improvement of low serum selenium concentration at 4 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sodium selenite at 100 to 200 micro g/day at day 1-7 in a week,4-week interval assessment. continued till symptoms associated with selenium deficiency were recuperated.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients at the age of 20 years or more during management of intravenous alimentation for one month or more 2.low serum concentration of selenium 3.written consent obtained 4. patients unable to have selenium supplementation per orally 5.likely appearance of symptoms suggestive of selenium deficiency if no selenium supplementation is continued 6. for inpatients and outpatients
Key exclusion criteria
1.patients allergy to sodium selenite 2.outpatients unable to communicate with others at emergency.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanida |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8211
stanida@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanida |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterology and Metabolism
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8211
Homepage URL
stanida@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
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
Address
Tel
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
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
2
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 | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031948
