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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044457
Receipt No. 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 2021/06/07

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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
Email 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
Email s-notomi@nagajin.jp

Sponsor
Institute Nagasaki kidney hospital
Institute
Department

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
Email 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 Preinitiation
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 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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