UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of blood concentration of magnesium after an oral intake
Title of the study (Brief title)	The investigation of blood concentration of magnesium after an oral intake
Region	Japan

Condition
Condition	not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate change of blood concentration o-f magunesium after oral intake for healthy men
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood concentration of ionized magnesium (before intaking magnesium,every 1 hour afte-r intaking magnesium until 6 hours)
Key secondary outcomes	blood concentration of ionized calcium, so-dium, potassium, and chloride (before intaking magnesium,every 1 hour af-ter intaking magnesium until 6 hours) oxidative stress antioxidative activity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	oral inyake of dietary supplement of magne-sium (after fasting which is commonly carried o-ut before genaral anesthesia) blood withdrawal (before intaking magnesium,every 1 hour af-ter intaking magnesium until 6 hours)
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	65 years-old >
Gender	Male
Key inclusion criteria	healthy adult male ASA PS1
Key exclusion criteria	ASA PS2-6 female under 20 years old over 65 years old
Target sample size	10

Research contact person
Name of lead principal investigator	Uemura Yuta
Organization	Tokushima Univeersity Hospital
Division name	Anesthesiology
Address	18-15,3 Kuramotochou,Tokushima city,Tokushima prefecture
TEL	0886337181
Email	uemura.yuuta@tokushima-u.ac.jp

Public contact
Name of contact person	Uemura Yuta
Organization	Tokushima University Hospital
Division name	Anesthesiology
Address	18-15,3 Kuramotochou,Tokushima city,Tokushima prefecture
TEL	0886337181
Homepage URL
Email	uemura.yuuta@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital Anesthesiology
Institute
Department

Funding Source
Organization	Tokushima University Hospital Anesthesiology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 05 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 14 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 14 Day
Last modified on	2018 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037159