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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048530
Receipt No. R000055208
Scientific Title The effect of simple salt-reduction education using estimated salt excretion, measured from spot urine samples in outpatients
Date of disclosure of the study information 2022/08/02
Last modified on 2022/08/01

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Basic information
Public title The effect of simple salt-reduction education using estimated salt excretion, measured from spot urine samples in outpatients
Acronym The effect of simple salt-reduction education using estimated salt excretion, measured from spot urine samples in outpatients
Scientific Title The effect of simple salt-reduction education using estimated salt excretion, measured from spot urine samples in outpatients
Scientific Title:Acronym The effect of simple salt-reduction education using estimated salt excretion, measured from spot urine samples in outpatients
Region
Japan

Condition
Condition hypertension
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate the effect of simple salt-reduction education using estimated salt excretion, measured from spot urine samples at each medical examination in outpatients. We compare the effects of simple salt-reduction education group with normal medical care group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of estimated salt excretion after 1 year
Key secondary outcomes The changes of estimated potassium excretion, sodium/potassium ratio, systolic BP, and diastolic BP after 1 year
Seasonal Variation in the daily urinary sodium excretion
The relationship of urinary sodium from the spot and 24-hour urine samples

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 Patients who measured urinary electrolytes in nephrology departments.
Key exclusion criteria Patients who use steroids, and medications that may cause fluctuations in sodium reabsorption such as loop diuretics and thiazide diuretics within 1 week of urinary electrolyte measurement.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Hisato
Middle name
Last name Shima
Organization Kawashima Hospital
Division name Nephrology
Zip code 770-0011
Address 6-1 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL 088-631-0110
Email h.shima@khg.or.jp

Public contact
Name of contact person
1st name Hisato
Middle name
Last name Shima
Organization Kawashima Hospital
Division name Nephrology
Zip code 770-0011
Address 6-1 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL 088-631-0110
Homepage URL
Email h.shima@khg.or.jp

Sponsor
Institute Kawashima Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawashima Hospital
Address 6-1 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
Tel 088-631-0110
Email h.shima@khg.or.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
2022 Year 08 Month 02 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 120
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 No longer recruiting
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 12 Month 08 Day
Anticipated trial start date
2020 Year 12 Month 08 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We observe the changes in estimated daily salt content, potassium intake, Na / K ratio, systolic blood pressure, and diastolic blood pressure.

Management information
Registered date
2022 Year 08 Month 01 Day
Last modified on
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055208

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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