UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031743 |
|---|---|
| Receipt number | R000036247 |
| Scientific Title | Clinical study of nutrition / health management based on plasma selenoprotein P level |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2018/03/15 16:27:45 |
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Basic information
Public title
Clinical study of nutrition / health management based on plasma selenoprotein P level
Acronym
CNM-SeP stduy
Scientific Title
Clinical study of nutrition / health management based on plasma selenoprotein P level
Scientific Title:Acronym
CNM-SeP stduy
Region
| Japan |
Condition
Condition
Arteriosclerosis
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with an advanced consciousness disorder are maintained healthy by enteral nutrition. Since enteral nutrient fluid does not contain essential trace element selenium, it has been reported that selenium deficiency occurs in case of long-term enteral nutrition. In generally, the check of selenium status is done by measuring selenium in plasma; however, for measurement of selenium, ICP-MS is necessary. We have constructed a measurement system for selenoprotein P present in plasma and have developed a diagnostic agent for selenoprotein P measurement that is compatible with automated analyzers used in general hospitals. In this research, we aim to clarify the clinical significance of SeP measurement diagnostic agent in monitoring nutrition / health condition of the patient.
Basic objectives2
Others
Basic objectives -Others
This research will propose the method to monitor selenium condition conveniently.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical significance of SeP measurement diagnostics
Key secondary outcomes
Simple selenium monitor
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with advanced consciousness disturbed nursing at the Chiba medical center
Key exclusion criteria
Cases judged inappropriate by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiro Saito |
Organization
Doshisha University
Division name
Faculty of Life and Medical Sciences
Zip code
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto 610-0321 JAPAN
TEL
0774-65-6258
ysaito@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Saito |
Organization
Doshisha University
Division name
Faculty of Life and Medical Sciences
Zip code
Address
1-3 Miyakodani, Tatara, Kyotanabe, Kyoto 610-0321 JAPAN
TEL
0774-65-6258
Homepage URL
ysaito@mail.doshisha.ac.jp
Sponsor or person
Institute
Faculty of Life and Medical Sciences, Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The diagnostic agent for measurement arrived at the Chiba Medical Center on March 1. We will start measuring at any time.
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036247
