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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000027883 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | selenium deficiency | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031948 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |
2019/03/29 | amcr-v1-id1005.pdf |