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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015511
Receipt No. 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 2016/04/28

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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
Last 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
Email kamefu@rb3.so-net.ne.jp

Public contact
1st 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
Email kamefu@rb3.so-net.ne.jp

Sponsor
Institute Seigato Hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2014 Year 11 Month 01 Day
Date of IRB
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
2016 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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