UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032630 |
|---|---|
| Receipt number | R000037205 |
| Scientific Title | Clinical study of the relationship between frailty and saliva components |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2019/08/13 10:53:32 |
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Basic information
Public title
Clinical study of the relationship between frailty and saliva components
Acronym
The relationship between frailty and saliva
Scientific Title
Clinical study of the relationship between frailty and saliva components
Scientific Title:Acronym
The relationship between frailty and saliva
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study determine whether frailty has an effect on the saliva components.
Basic objectives2
Others
Basic objectives -Others
The analysis of saliva components in frailty
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The saliva components are analyses using metabolomic analysis and ELISA.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
When we show the change of saliva components and the index of frailty, we provide registered dietitian at the university hospital and primary care physician.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents in Samukawa Home or Honobono.
Patients in Kanagawa dental university hospital.
Key exclusion criteria
Subject with percutaneous endoscopic gastrostomy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | To |
Organization
Graduate School of Dentistry, Kanagawa Dental University
Division name
Department of Oral Science
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
0468229537
m.tou@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | To |
Organization
Graduate School of Dentistry, Kanagawa Dental University
Division name
Department of Oral Science
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
0468229537
Homepage URL
m.tou@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute for Advanced Biosciences, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
82 Inaoka-cho, Yokosuka, Kanagawa
Tel
0468229537
m.tou@kdu.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
| 2019 | Year | 01 | Month | 01 | 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
| 2018 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 17 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037205
