UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015511 |
|---|---|
| Receipt number | R000018020 |
| Scientific Title | Spot urine-guided salt reduction approach in hosital staff |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2023/10/30 10:19:33 |
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Basic information
Public title
Spot urine-guided salt reduction approach in hosital staff
Acronym
SPRED-HS
Scientific Title
Spot urine-guided salt reduction approach in hosital staff
Scientific Title:Acronym
SPRED-HS
Region
| Japan |
Condition
Condition
No restriction
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether information of daily salt intake in individual patients by spot urine-guided approach can contribute to salt reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
annual changes in daily salt intake
Key secondary outcomes
1. annual changes in blood pressure
2. incidence of cardiovascular events
3. incidence of total death
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospital staff who received annual check-up examination
Key exclusion criteria
No exclusion criteria
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneaki Sadanaga |
Organization
Seigato Hospital
Division name
Director
Zip code
Address
Funatsu 897, Kawachi, Nishiku, Kumamoto
TEL
096-276-1151
kamefu@rb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuneaki Sadanaga |
Organization
Seigato Hospital
Division name
Director
Zip code
Address
Funatsu 897, Kawachi, Nishiku, Kumamoto
TEL
096-276-1151
Homepage URL
kamefu@rb3.so-net.ne.jp
Sponsor or person
Institute
Seigato Hospital
Institute
Department
Personal name
Funding Source
Organization
Seigato Hospital
Organization
Division
Category of Funding Organization
Self funding
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
聖ヶ塔病院（熊本県）、西日本病院（熊本県）
Seigato Hospital(Kumamoto), Nishinihon Hospital(Kumamoto)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Annual follow up of daily salt intake and blood pressure. Incidence of cardiovascular events and death are cheked during observational period.
Management information
Registered date
| 2014 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018020
| 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 |
