UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044457 |
|---|---|
| Receipt number | R000050784 |
| Scientific Title | Evaluation of malnutrition in chronic hemodialysis patiens using NRI-JH(nutritional risk index for Japanese hemodialysis patients) and consideration of intervention methods |
| Date of disclosure of the study information | 2021/06/08 |
| Last modified on | 2021/08/02 14:31:33 |
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Basic information
Public title
Evaluation of malnutrition in chronic hemodialysis patiens using NRI-JH(nutritional risk index for Japanese hemodialysis patients) and consideration of intervention methods
Acronym
Evaluation of malnutrition in chronic hemodialysis patiens using NRI-JH(nutritional risk index for Japanese hemodialysis patients) and consideration of intervention methods
Scientific Title
Evaluation of malnutrition in chronic hemodialysis patiens using NRI-JH(nutritional risk index for Japanese hemodialysis patients) and consideration of intervention methods
Scientific Title:Acronym
Evaluation of malnutrition in chronic hemodialysis patiens using NRI-JH(nutritional risk index for Japanese hemodialysis patients) and consideration of intervention methods
Region
| Japan |
Condition
Condition
choronic hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early detection of malnutrition in chtonic hemodialysis patients and improvement of nutritonal status.
Consideration of apporopriate nutritional intervention metods for malnutrition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRI-JH score
Key secondary outcomes
NRI-JH score items(BMI,serum albumin level,serum total cholesterol,serum Creatinine)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutritional counseling
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients chronic hemodialysis
Key exclusion criteria
Patients with CVDs
Patients with CRP value of 0.5 or more in regular blood test
Patients with cancer
Patients who do not want nutritional counceling
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Satokno |
| Middle name | |
| Last name | Notomi |
Organization
Nagasaki kidney hospital
Division name
Department of nurtrition
Zip code
8500032
Address
5-1,Kozanmachi,Nagasaki
TEL
0958241101
s-notomi@nagajin.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Notomi |
Organization
Nagasaki kidney hospital
Division name
Department of nutrition
Zip code
8500032
Address
5-1,Kozenmachi,Nagasaki
TEL
0958241101
Homepage URL
s-notomi@nagajin.jp
Sponsor or person
Institute
Nagasaki kidney hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki kidney hospital
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
20003
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 | 06 | Month | 08 | 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 | 06 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 07 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050784
