UMIN-CTR Clinical Trial

Basic information
Public title	Regional survey of salt intake by presumptive salt intake-measurement with spot urine.
Acronym	Regional survey of salt intake with spot urine.
Scientific Title	Regional survey of salt intake by presumptive salt intake-measurement with spot urine.
Scientific Title:Acronym	Regional survey of salt intake with spot urine.
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Regional difference assessment of salt intake by presumptive salt intake-measurement with spot urine.
Basic objectives2	Others
Basic objectives -Others	Regional survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presumptive salt-intake (sodium, and creatinine) Na/K ratio (sodium, and potassium)
Key secondary outcomes

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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Persons who give written informed consent, and have full ethical and regulatory approval 2. Healthy Japanese men and women over 20 years old, or aged 12~19 who got the consent of their guardians
Key exclusion criteria	None
Target sample size	10000

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Tsuchihashi
Organization	Steel Memorial Yawata Hospital
Division name	President / hospital director
Zip code	805-0050
Address	1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu City Fukuoka Pref., 805-8508, JAPAN
TEL	093-672-3140
Email	tuti@ns.yawata-mhp.or.jp

Public contact
Name of contact person	1st name Takanori Middle name Last name Yasutake
Organization	Healthcare Systems Co., Ltd.
Division name	Marketing and Sales Promotion Division
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, 105-0004, JAPAN
TEL	03-6809-2722
Homepage URL
Email	yasutake@hc-sys.jp

Sponsor
Institute	Steel Memorial Yawata Hospital
Institute
Department

Funding Source
Organization	Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shiga University of medical science. Healthcare Systems Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	STEEL MEMORIAL YAWATA HOSPITAL Ethical Review Board
Address	1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu City Fukuoka Pref., 805-8508, JAPAN
Tel	093-672-3176
Email	tanaka.ya@ns.yawata-mhp.or.jp

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 01 Month 15 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	10071
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	2017 Year 11 Month 20 Day
Date of IRB	2017 Year 11 Month 20 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Many of the survey of salt intake until now have used survey forms. In this trial, actual measurement of presumptive salt intake and Na/K ratio is carried out and an regional survey of salt intake by is conducted.

Management information
Registered date	2018 Year 01 Month 15 Day
Last modified on	2020 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035179