UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045566 |
|---|---|
| Receipt number | R000051882 |
| Scientific Title | Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients |
| Date of disclosure of the study information | 2021/09/25 |
| Last modified on | 2022/09/06 12:48:36 |
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Basic information
Public title
Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Acronym
Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Scientific Title
Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Scientific Title:Acronym
Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Region
| Japan |
Condition
Condition
Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the appetite of elderly hemodialysis patients and analyze the factors that affect appetite loss.
Basic objectives2
Others
Basic objectives -Others
Factor analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SNAQ-JE score
Key secondary outcomes
Nutritional index(Albumin,GNRI,NRI-JH)
Blood test(ChE,TO,T-Cho,UN,Cr,CRP,Hb,nPCR and others)
Age, dialysis history, medical history, BMI and others
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
outpatients dialysis patients
Key exclusion criteria
Patients who disagree with the questionnaire survey using SNAQ-JE
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Notomi |
Organization
Nagasaki Renal Center
Division name
Department of nutrition
Zip code
850-0032
Address
5-1,Kozenmachi,Nagasaki
TEL
095-824-1101
s-notomi@nagajin.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Notomi |
Organization
Nagasaki Renal Center
Division name
Department of nutrition
Zip code
850-0032
Address
5-1, Kozenmachi Nagasaki
TEL
095-824-1101
Homepage URL
s-notomi@nagajin.jp
Sponsor or person
Institute
Nagasaki Renal Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Nagasaki kidney hospital
Address
5-1,Kozenmachi. Nagasaki
Tel
095-824-1101
r-koma@nagajin.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21012
Org. issuing International ID_1
Ethical committee of Nagasaki kidney hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長崎腎病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 25 | 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
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
All patients who underwent hemodialysis at our facility in September-December 2021 who met the selection criteria
Management information
Registered date
| 2021 | Year | 09 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051882
