UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048530 |
|---|---|
| Receipt number | 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 | 2023/08/04 12:07:57 |
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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
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
h.shima@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055208
