UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030810 |
|---|---|
| Receipt number | R000035179 |
| Scientific Title | Regional survey of salt intake by presumptive salt intake-measurement with spot urine. |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2020/01/21 10:55:34 |
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Basic information
Public title
Regional survey of salt intake by presumptive salt intake-measurement with spot urine.
Acronym
Regional survey of salt intake with spot urine.
Scientific Title
Regional survey of salt intake by presumptive salt intake-measurement with spot urine.
Scientific Title:Acronym
Regional survey of salt intake with spot urine.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regional difference assessment of salt intake by presumptive salt intake-measurement with spot urine.
Basic objectives2
Others
Basic objectives -Others
Regional survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presumptive salt-intake (sodium, and creatinine)
Na/K ratio (sodium, and potassium)
Key secondary outcomes
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who give written informed consent, and have full ethical and regulatory approval
2. Healthy Japanese men and women over 20 years old, or aged 12~19 who got the consent of their guardians
Key exclusion criteria
None
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Tsuchihashi |
Organization
Steel Memorial Yawata Hospital
Division name
President / hospital director
Zip code
805-0050
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu City Fukuoka Pref., 805-8508, JAPAN
TEL
093-672-3140
tuti@ns.yawata-mhp.or.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Yasutake |
Organization
Healthcare Systems Co., Ltd.
Division name
Marketing and Sales Promotion Division
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, 105-0004, JAPAN
TEL
03-6809-2722
Homepage URL
yasutake@hc-sys.jp
Sponsor or person
Institute
Steel Memorial Yawata Hospital
Institute
Department
Personal name
Funding Source
Organization
Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga University of medical science.
Healthcare Systems Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
STEEL MEMORIAL YAWATA HOSPITAL Ethical Review Board
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyushu City Fukuoka Pref., 805-8508, JAPAN
Tel
093-672-3176
tanaka.ya@ns.yawata-mhp.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
| 2018 | Year | 01 | Month | 15 | 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
10071
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 | 11 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Many of the survey of salt intake until now have used survey forms. In this trial, actual measurement of presumptive salt intake and Na/K ratio is carried out and an regional survey of salt intake by is conducted.
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035179
