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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039214
Receipt No. R000044691
Scientific Title Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients
Date of disclosure of the study information 2020/01/21
Last modified on 2020/01/21

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Basic information
Public title Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients
Acronym Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients
Scientific Title Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients
Scientific Title:Acronym Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients
Region
Japan

Condition
Condition Hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between sarcopenia and nutritional indicators and dietary intake status of elderly hemodialysis patients
Basic objectives2 Others
Basic objectives -Others Provide nutritional intervention for patients with sarcopenia.
Review sarcopenia every year.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Sarcopenia
2.Food intake status
3.Nutrition index

Evaluation at the beginning of the study, every year, and at the end of the study
Key secondary outcomes 1.Laboratory test values
2.Body component analysis
3.Grip strength,5CS

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Nutrition intervention for sarcopenia group to achieve 7/10 or more based on food intake diversity score (DVS)
Interventions/Control_2 Regular practice
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 1.Outpatient hemodialysis patients aged 65 and over
2.Patients with sarcopenia
Key exclusion criteria 1.Patients who have difficulty communicating
2.Patients who cannot diagnose sarcopenia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name kana
Middle name
Last name iwasa
Organization Kawashima-kai, a social medical corporation Kawashima Hospital
Division name Nutrition management room
Zip code 770-0011
Address 1-39 Kitasako Ichibancho, Tokushima City, Tokushima Prefecture
TEL 088-631-0110
Email k.iwasa@khg.or.jp

Public contact
Name of contact person
1st name kana
Middle name
Last name iwasa
Organization Kawashima-kai, a social medical corporation Kawashima Hospital
Division name Nutrition management room
Zip code 770-0011
Address 1-39 Kitasako Ichibancho, Tokushima City, Tokushima Prefecture
TEL 088-631-0110
Homepage URL
Email k.iwasa@khg.or.jp

Sponsor
Institute Kawashima-kai, a social medical corporation Kawashima Hospital
Institute
Department

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 Kawashima-kai, a social medical corporation Kawashima Hospital
Address 1-39 Kitasako Ichibancho, Tokushima City, Tokushima Prefecture
Tel 088-631-0110
Email k.iwasa@khg.or.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
2020 Year 01 Month 21 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
2019 Year 12 Month 25 Day
Date of IRB
2020 Year 01 Month 07 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2023 Year 09 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
2020 Year 01 Month 21 Day
Last modified on
2020 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044691

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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