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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name