UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040835 |
|---|---|
| Receipt number | R000046620 |
| Scientific Title | Study on the relationship between amount of salt intake and consciousness of salt intake |
| Date of disclosure of the study information | 2020/06/19 |
| Last modified on | 2022/12/20 11:49:35 |
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Basic information
Public title
Study on the relationship between amount of salt intake and consciousness of salt intake
Acronym
Study on the relationship between amount of salt intake and consciousness of salt intake
Scientific Title
Study on the relationship between amount of salt intake and consciousness of salt intake
Scientific Title:Acronym
Study on the relationship between amount of salt intake and consciousness of salt intake
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the relationship between amount of salt intake and consciousness of salt intake from the results of the Siocheck (salt reduction test) and the results of the questionnaire survey on the consciousness of salt intake.
Basic objectives2
Others
Basic objectives -Others
relationship between amount of salt intake and consciousness of salt intake
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire before and after the salt reduction test
Key secondary outcomes
Estimated salt intake (sodium and creatinine in urine)
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
| 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 study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Male and female who are 20 years old or more
Key exclusion criteria
1. Persons who participate in other clinical studies or participated in the last 1 months or plan to participate in other clinical studies.
2. Persons who were judged as inappropriate for subjects by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yasutake |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales Planning Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
yasutake@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Yasutake |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales Planning Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
yasutake@hc-sys.jp
Sponsor or person
Institute
My life Co., Ltd.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2020 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Terminated before the start of the study
Publication of results
Unpublished
Result
URL related to results and publications
Terminated before the start of the study
Number of participants that the trial has enrolled
0
Results
Terminated before the start of the study
Results date posted
| 2022 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Terminated before the start of the study
Participant flow
Terminated before the start of the study
Adverse events
Terminated before the start of the study
Outcome measures
Terminated before the start of the study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To verify the relationship between amount of salt intake and consciousness of salt intake
Management information
Registered date
| 2020 | Year | 06 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
