UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044339 |
|---|---|
| Receipt number | R000050641 |
| Scientific Title | Development of a method for estimating dietary salt intake using overnight urine |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2024/05/28 09:11:17 |
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Basic information
Public title
Development of a method for estimating dietary salt intake using overnight urine
Acronym
Development of a method for estimating dietary salt intake using overnight urine
Scientific Title
Development of a method for estimating dietary salt intake using overnight urine
Scientific Title:Acronym
Development of a method for estimating dietary salt intake using overnight urine
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of estimation equation
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to develop a method for estimating dietary salt intake using overnight urinary sodium (Na) / potassium (K) ratios.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
an equation for estimating dietary salt intake using overnight urinary Na/K ratio
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
| Food |
Interventions/Control_1
salt-adjusted diet : 3-15g
period : 3-10 days
(We plan to design with various salt intake and period patterns.)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
Patients (especially hypertension, renal dysfunction)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Tsukahara |
Organization
Nagoya University of Arts and Sciences
Division name
Department of Nutritional Sciences
Zip code
470-0196
Address
57 Takenoyama Iwasaki-cho Nisshin-city Aichi pref.
TEL
0561-75-2584
ttsuka@nuas.ac.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Tsukahara |
Organization
Nagoya University of Arts and Sciences
Division name
Department of Nutritional Sciences
Zip code
470-0196
Address
57 Takenoyama Iwasaki-cho Nisshin-city Aichi pref.
TEL
0561-75-2584
Homepage URL
ttsuka@nuas.ac.jp
Sponsor or person
Institute
Nagoya University of Arts and Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya University of Arts and Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
LIXIL Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Nagoya University of Arts and Sciences.
Address
57 Takenoyama Iwasaki-cho Nisshin-city Aichi pref.
Tel
0561-75-2584
ttsuka@nuas.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
| 2021 | Year | 05 | Month | 31 | 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
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050641
