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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name