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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033296
Receipt No. R000037958
Official scientific title of the study Investigation on behavior / salt intake transition with or without notification of salt intake
Date of disclosure of the study information 2018/07/05
Last modified on 2018/09/11

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Basic information
Official scientific title of the study Investigation on behavior / salt intake transition with or without notification of salt intake
Title of the study (Brief title) 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
Name of lead principal investigator Tomohiro Katsuya
Organization Katsuya Clinic
Division name Director
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
Name of contact person Takanori Yasutake
Organization Healthcare Systems Co., Ltd.
Division name Marketing and Sales Promotion Division
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 15 Day
Anticipated trial start date
2018 Year 09 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 07 Month 05 Day
Last modified on
2018 Year 09 Month 11 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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