UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007241 |
|---|---|
| Receipt number | R000008531 |
| Scientific Title | Randomized trial on the effect of monitoring urinary sodium / potassium ratio on dietary habit improvement |
| Date of disclosure of the study information | 2012/02/07 |
| Last modified on | 2013/03/26 10:30:41 |
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Basic information
Public title
Randomized trial on the effect of monitoring urinary sodium / potassium ratio on dietary habit improvement
Acronym
The effect of monitoring urinary sodium / potassium ratio
Scientific Title
Randomized trial on the effect of monitoring urinary sodium / potassium ratio on dietary habit improvement
Scientific Title:Acronym
The effect of monitoring urinary sodium / potassium ratio
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
2
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. Leaflets with dietary education information will also be handed out.
Interventions/Control_2
Conventional dietary improvement program will be applied for the control group. Leaflets with dietary education information will be handed out.
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
| 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
96
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
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
miura@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
| 2012 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Baseline
_Urinary Na/K ratio was 3.78 in intervention group and 3.64 in control group.
_Urinary Na was 199.2mmol (11.6g) in intervention group and 191.8mmol (11.2g) in control group.
_Urinary K was 56.4mmol (2.2g) in intervention group and 53.4mmol (2.1g) in control group.
Difference in urinary Na/K ratio before & after intervention
_Reduced 0.55 in intervention group and also reduced 0.05 in control group.
_No statistical significance observed in change of urinary Na/K ratio between intervention group and control group (p=0.09).
Difference in urinary Na before & after intervention
_Reduced 18.6mmol (1.1g) in intervention group and also reduced 8.8mmol (0.5g) in control group.
_No statistical significance observed in change of urinary Na between intervention group and control group (p=0.53).
Difference in urinary K before & after intervention
_Increased 2.5mmol (0.1g) in intervention group and reduced 1.5mmol (0.06g) in control group.
_No statistical significance observed in change of urinary Na between intervention group and control group (p=0.30).
Frequency of use of device in intervention group: average 2.77 [times/day] (Maximum: 7 [times/day])
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
| 2011 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 07 | Day |
Last modified on
| 2013 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008531
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