UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023788 |
|---|---|
| Receipt number | R000026934 |
| Scientific Title | Effect of self-monitoring salt intake for salt reduction A Non-Blinded Cluster Randomized Trial |
| Date of disclosure of the study information | 2016/08/27 |
| Last modified on | 2017/08/02 09:01:52 |
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Basic information
Public title
Effect of self-monitoring salt intake for salt reduction
A Non-Blinded Cluster Randomized Trial
Acronym
The effect of self-monitoring salt intake
Scientific Title
Effect of self-monitoring salt intake for salt reduction
A Non-Blinded Cluster Randomized Trial
Scientific Title:Acronym
The effect of self-monitoring salt intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of self-monitoring salt intake for salt reduction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimated daily salt intake by spot urine 4 weeks after intervention
Key secondary outcomes
Blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Usual education for salt reduction (60 minutes lecture by a general physician and a registered dietitian) and self-monitoring salt intake by a simple device
Interventions/Control_2
Usual education for salt reduction (60 minutes lecture by a general physician and a registered dietitian)
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
Applicants to an advertisement by Shirakawa General Kosei Hospital, Nishigo village, Shirakawa city, and Japan agricultural Cooperative Yumeminami branch
Key exclusion criteria
Families who do not live with participants
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Takada |
Organization
Fukushima Medical University
Division name
Shirakawa Satellite for Teaching And Research in General Medicine
Zip code
Address
2-1, Toyochikamiyajiro Shirakawa, Fukushima, 961-0005
TEL
0248-22-2211
ttakada@water.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Takada |
Organization
Fukushima Medical University
Division name
Shirakawa Satellite for Teaching And Research in General Medicine
Zip code
Address
2-1, Toyochikamiyajiro Shirakawa, Fukushima, 961-0005
TEL
0248-22-2211
Homepage URL
ttakada@water.ocn.ne.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culuture,Sports,Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
白河厚生総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 27 | 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
| 2016 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 27 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026934
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
