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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name