UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019806 |
|---|---|
| Receipt number | R000022888 |
| Scientific Title | Comparison of urinary sodium potassium ratio by nutritional counseling; dietary salt reduction and with increasing dietary potassium |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2019/02/18 10:37:13 |
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Basic information
Public title
Comparison of urinary sodium potassium ratio by nutritional counseling; dietary salt reduction and with increasing dietary potassium
Acronym
Comparison of urinary sodium potassium ratio by nutritional counseling; dietary salt reduction and with increasing dietary potassium (Na-K Study)
Scientific Title
Comparison of urinary sodium potassium ratio by nutritional counseling; dietary salt reduction and with increasing dietary potassium
Scientific Title:Acronym
Comparison of urinary sodium potassium ratio by nutritional counseling; dietary salt reduction and with increasing dietary potassium (Na-K Study)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypertension is associated with taking the amount of sodium and potassium intake. Though dietary salt reduction has been introduced as a way of nutritional counselling, increasing potassium has not been recognized. Recently, urinary sodium and potassium ratio could be measured by the portable device. Through the measurement of urinary sodium and potassium ratio, we compare the nutritional counseling by reducing dietary salt with by salt reduction and increasing potassium.
Basic objectives2
Others
Basic objectives -Others
Through the measurement of urinary sodium and potassium ratio, we compare the nutritional counseling by reducing dietary salt with by salt reduction and increasing potassium.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of urine sodium excretion in 24 hour urine collection.
The amount of urine potassium excretion in 24 hour urine collection.
Urinary sodium and potassium ratio (24-hour urine collection)
Measuring urinary sodium and potassium ratio with portable device.
Key secondary outcomes
Blood pressure
(On starting and finishing the study)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Group nutritional counselling (dietary salt reduction; once)
Individual nutritional counselling (dietary salt reduction; twice)
Interventions/Control_2
Group nutritional counselling (dietary salt reduction and increasing potassium intake; once)
Individual nutritional counselling (dietary salt reduction and increasing potassium intake; twice)
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
40-60 years old male and female
Systolic blood pressure more than 140 mmHg or Diastolic blood pressure more than 90 mmHg on health examination.
Under treatment of hypertension.
Key exclusion criteria
･ Disapproval
･Starting or changing the medications for hypertension within 3 months
･ Secondary hypertension
･ Ischemic heart disease or stroke
･ Renal disorder (proteinuria or hematuria)
･ Nutrition counselling has been undesired.
･ Potassium intake has been undesired.
･Arrhythmia
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Okamura |
Organization
Keio University School of Medicine
Division name
Department of Preventive Medicine and Public health
Zip code
Address
35 Shinanomachi Shinjyuku-ku, Tokyo, Japan
TEL
03-5363-3758
okamura@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyo Kuwabara |
Organization
Keio University School of Medicine
Division name
Department of Preventive Medicine and Public health
Zip code
Address
35 Shinanomachi Shinjyuku-ku, Tokyo, Japan
TEL
03-5363-3758
Homepage URL
kuwabara@keio.jp
Sponsor or person
Institute
Department of Preventive Medicine and Public Health, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The research grant of The Japanese Society of Cardiovascular Disease Prevention
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 30 | 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
In December 2015, the intervention on the small scale was carried out. The number of subjects registered was 2 (male) and it was confirmed that there was no problem in the intervention protocol in the work area.
The target was recruited from January to February 2017, and the actual intervention was conducted in January to March of the same year divided into 6 courses. The number of new registrants was ten (total of 13 registered as of November 20, 2017). The urinary sodium potassium ratio showed a downward trend in both groups in the 2 weeks of the study period. There was no statistically significant difference before and after the intervention of both groups and each group, but the urinary sodium potassium ratio fell more in the intervention group than in the control group.
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
| 2015 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022888
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/12/03 | 修正_研究計画書_第3版20161128承認版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
