UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033296 |
|---|---|
| Receipt number | R000037958 |
| Scientific Title | 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 | 2019/04/09 10:25:09 |
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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
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
tkatsuya@iris.eonet.ne.jp
Public contact
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
yasutake@hc-sys.jp
Sponsor or person
Institute
Katsuya Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037958
