UMIN-CTR Clinical Trial

Basic information
Public title	Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement
Acronym	The effect of monitoring urinary sodium / potassium ratio with support program
Scientific Title	Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement
Scientific Title:Acronym	The effect of monitoring urinary sodium / potassium ratio with support program
Region	Japan

Condition
Condition	Hypertensive individuals Healthy individuals
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the effect of lowering the sodium / potassium (Na/K) ratio on dietary improvement through use of a spot urine monitoring device and a conventional dietary education program.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sodium / potassium ratio in 24-hour urine collections
Key secondary outcomes	1. Sodium excretion and potassium excretion in 24-hour urine collections 2. Blood pressure 3. Dietary habit by survey

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Monitoring system and the conventional dietary program will be applied for the intervention group. This group will have additional monitoring via measurement of Na/K ratio in casual urine. 7 inch tablet device with dietary education software program will be installed and leaflets with dietary education information will be also handed out.
Interventions/Control_2	Monitoring system and the conventional dietary program will be applied for the intervention group. This group will have additional monitoring via measurement of Na/K ratio in casual urine. Leaflets with dietary education information will be also handed out.
Interventions/Control_3	Conventional dietary improvement program will be applied for the control group. Leaflets with dietary education information will be handed out.
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	40 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	_Healthy and hypertensive individuals _No change on drugs at least a month for hypertensive individuals _People who are able to use the device _People who are able to record the result _People who are able to participate on 24H urine collection
Key exclusion criteria	_Kidney disease, CVD, DM _Secondary hypertension _SBP over 180mmHg, DBP over 110mmHg _Shift workers _People who cannot understand the dietary improvement information
Target sample size	162

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuyuki Miura
Organization	Shiga University of Medical Science
Division name	Department of Health Science
Zip code
Address	Seta Tsukinowa-chou, Otsu, Shiga
TEL	077-548-2191
Email

Public contact
Name of contact person	1st name Middle name Last name Katsuyuki Miura
Organization	Shiga University of Medical Science
Division name	Department of Health Science
Zip code
Address	Seta Tsukinowa-chou, Otsu, Shiga
TEL	077-548-2191
Homepage URL
Email	miura@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Omron Healthcare Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Omron Healthcare Co., Ltd. Omron Personnel Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	オムロンヘルスケア株式会社本社ビル(京都府)

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 27 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	Terminated
Date of protocol fixation	2012 Year 11 Month 27 Day
Date of IRB	2012 Year 12 Month 25 Day
Anticipated trial start date	2013 Year 01 Month 26 Day
Last follow-up date	2013 Year 03 Month 16 Day
Date of closure to data entry	2013 Year 08 Month 31 Day
Date trial data considered complete	2013 Year 12 Month 15 Day
Date analysis concluded	2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 01 Month 22 Day
Last modified on	2021 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011498