UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027377 |
|---|---|
| Receipt number | R000031371 |
| Scientific Title | The trial of the assessment of newly personal device for detection urinary Na/K ratio with low-salt meal in healthy volunteers |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2021/11/16 20:49:24 |
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Basic information
Public title
The trial of the assessment of newly personal device for detection urinary Na/K ratio with low-salt meal in healthy volunteers
Acronym
The trial of newly personal device for urinary Na/K ratio with low-salt meal
Scientific Title
The trial of the assessment of newly personal device for detection urinary Na/K ratio with low-salt meal in healthy volunteers
Scientific Title:Acronym
The trial of newly personal device for urinary Na/K ratio with low-salt meal
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthy volunteers (30 subjects) ingest standardized low- (6g NaCl /day) and normal-Na (12g NaCl /day) meals for 6 days each. We evaluate the characteristics of newly developed personal device for urinary Na/K ratio and salt monitor for estimation of daily salt intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference both urinary Na/K ratio and estimation of daily salt intake, between the 6th day of low salt dietary intake period and 6th day of regular diet intake period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Healthy volunteers ingest standardized low- (6g NaCl /day) and normal-Na (12g NaCl /day) meals for 6 days each.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult volunteers meet all the following criteria.
1. Healthy volunteers recognized by investigator
2. Only prepared meal during the examination period
3. 3 meals (breakfast, lunch, dinner) at the designated time during the examination period
4. male
5. Agreement document for the trial entry
Key exclusion criteria
Those who conflict with any of the following are excluded from this examination.
1. Volunteer has hypertension, diabetes or chronic kidney disease
2. Volunteer has a history of diabetes, cardiovascular disease, cerebrovascular disease or chronic kidney disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Arakawa |
Organization
Nihon University, School of Pharmacy
Division name
Laboratory of Pharmaceutical Regulatory Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba
TEL
047-465-6292
arakawa.motoki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Arakawa |
Organization
Nihon University, School of Pharmacy
Division name
Laboratory of Pharmaceutical Regulatory Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba
TEL
047-465-6292
Homepage URL
arakawa.motoki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Japanese Study Group for Physiology and Management of Blood Pressure / Nihon University
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
Ethical review committee for Medical and Health Research Involving Human Subjects
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba
Tel
047-465-2383
enishi.jun@nihon-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
日本大学薬学部(千葉県)、富士通クリニック(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34569491/
Number of participants that the trial has enrolled
27
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
| 2017 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 17 | Day |
Last modified on
| 2021 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031371
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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