UMIN-CTR Clinical Trial

Basic information
Public title	Investigation on behavior / salt intake transition with or without notification of salt intake
Acronym	Investigation on behavior / salt intake transition with or without notification of salt intake
Scientific Title	Investigation on behavior / salt intake transition with or without notification of salt intake
Scientific Title:Acronym	Investigation on behavior / salt intake transition with or without notification of salt intake
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology Nephrology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For adult males and females aged 20 years or older, estimated salt intake is measured by spot urine. Participants are divided into two groups; the result is notified to one group, and not notified to the other, and evaluate whether difference in salt reduction behavior, salt intake, etc. appears.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presumptive salt-intake (sodium, and creatinine) at the beginning of the test or after 4, 8 weeks
Key secondary outcomes	Physical examination (blood pressure, pulse rate), questionnaire, at the beginning of the test or after 4, 8 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Notify the result of the estimated salt intake.
Interventions/Control_2	Do not notify the result of the estimated salt intake.
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.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Japanese who is 20 years old or more
Key exclusion criteria	1.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement 2.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period 3.Persons who are judged inappropriate for the exam by the principal investigator
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Tomohiro Katsuya
Organization	Katsuya Clinic
Division name	Director
Zip code
Address	2-17-21, Nanamatsu-cho, Amagasaki city, Hyogo Pref., 660-0052, JAPAN
TEL	06-6416-1684
Email	tkatsuya@iris.eonet.ne.jp

Public contact
1st name of contact person	1st name Middle name Last name Takanori Yasutake
Organization	Healthcare Systems Co., Ltd.
Division name	Marketing and Sales Promotion Division
Zip code
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, 105-0004, JAPAN
TEL	0368092722
Homepage URL
Email	yasutake@hc-sys.jp

Sponsor
Institute	Katsuya Clinic
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
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	2018 Year 07 Month 05 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	Completed
Date of protocol fixation	2018 Year 06 Month 15 Day
Date of IRB	2018 Year 06 Month 15 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2019 Year 01 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 05 Day
Last modified on	2019 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037958