UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030934 |
|---|---|
| Receipt number | R000035331 |
| Scientific Title | Sodium reduction trial by urinary Na/K self-monitoring |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/01/24 10:01:51 |
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Basic information
Public title
Sodium reduction trial by urinary Na/K self-monitoring
Acronym
The Naghama Na/K Trial
Scientific Title
Sodium reduction trial by urinary Na/K self-monitoring
Scientific Title:Acronym
The Naghama Na/K Trial
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an effect of urinary Na/K self-monitoring on salt intake and blood pressure levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in spot-urine Na/K at one and two month after starting the intervention.
Key secondary outcomes
Changes in sodium intake measured using 24-hour urine sample, and blood pressure and body weight measured at home.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self monitoring of urinary Na/K at home
One-month cross-over design
Interventions/Control_2
Self monitoring of blood pressure, body composition, and step counts at home.
Two-month including the Na/K self-monitoring period.
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
| 34 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants in the Nagahama study
Key exclusion criteria
Pregnancy
Hemodialysis
Pacemaker implantation
Insulin therapy
Renal functional decline [renal failure, chronic kidney disease, nephrosis syndrome]
Albuminuria [>++ by urine test paper, or urinary albumin >100 mg/dl]
Hepatic diseases [cirrhosis, hepatic failure]
Heart diseases [ischemic diseases, heart failure, bradycardia, arrhythmia]
Cancer
Chronic inflammatory bowel disease
Chronic diarrhea, or history of dehydration
Orthostatic dysregulation, or syncope
Hypotension [systolic blood pressure <100 mmHg]
Low body weigh [body mass index <16.5 kg/m2]
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Tabara |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
6068507
Address
Shogoinkawara-cho, Sakyo-ku, Kyoto
TEL
075-751-4157
tabara@genome.med.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Tabara |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
Shogoinkawara-cho, Sakyo-ku, Kyoto
TEL
075-751-4157
Homepage URL
tabara@genome.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagahama City
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2018 | Year | 04 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035331
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
