UMIN-CTR Clinical Trial

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
Email	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
Email	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
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	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
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

Contact us.