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 2023/05/28 14:06:51

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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

Email

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


Email

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

Email

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

Enrolling by invitation

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


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 05 Month 26 Day

Last modified on

2023 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name