UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050329 |
|---|---|
| Receipt number | R000057050 |
| Scientific Title | Evaluation of efficacy of dietary program for hypertensive patients |
| Date of disclosure of the study information | 2023/02/20 |
| Last modified on | 2024/07/16 17:02:02 |
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Basic information
Public title
Evaluation of efficacy of dietary program for hypertensive patients
Acronym
Evaluation of efficacy of dietary program for hypertensive patients
Scientific Title
Evaluation of efficacy of dietary program for hypertensive patients
Scientific Title:Acronym
Evaluation of efficacy of dietary program for hypertensive patients
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of dietary program containing visualizing nutritional status on modification of dietary habits
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Molar ratio of urinary sodium/potassium concentration
Key secondary outcomes
Home blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Notification of measurement result of urinary sodium/potassium ratio
Interventions/Control_2
Notification of measurement result of urinary sodium/potassium ratio and providing dietary program through the smartphone APP.
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
Hypertensive patients over 20 years of age receiving any care (e.g., medication) for hypertension at "TELEMEDEASE" services using smartphone.
The definition of hypertensive patients is those who use TELEMEDEASE hypertension telemedicine support application and are taking measures to control their hypertension, regardless of their blood pressure levels or whether or not they are taking medication.
Key exclusion criteria
Those who have kidney disease or abnormal renal function and are restricted in salt and potassium intake.
Those who participate other clinical studies.
Those who are considered inappropriate by principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
3292762
Address
17 Nishitomiyama, Nasushiobara, Tochigi
TEL
0287362935
Yusuke_Ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
3292762
Address
17 Nishitomiyama, Nasushiobara, Tochigi
TEL
0287362935
Homepage URL
Yusuke_Ushida@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
3-21-1 Nihonbashihamacho. chuo-ku, Tokyo
Tel
03-5623-8501
Toshika_Okuni@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-R15
Org. issuing International ID_1
Kagome Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057050
