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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023765
Receipt No. R000027383
Scientific Title An attempt to improve nutritional status in elderly hemodialysis patients with poor nutritional intake
Date of disclosure of the study information 2016/08/26
Last modified on 2016/08/25

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Basic information
Public title An attempt to improve nutritional status in elderly hemodialysis patients with poor nutritional intake
Acronym Improving Nutritional Status in Elderly Hemodialysis Patients
Scientific Title An attempt to improve nutritional status in elderly hemodialysis patients with poor nutritional intake
Scientific Title:Acronym Improving Nutritional Status in Elderly Hemodialysis Patients
Region
Japan

Condition
Condition Chronic Renal Failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve nutritional intake in elderly patients by reducing the amount of the main and side dishes and by adding a liquid food
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy endpoints:
1)Proportion of the regimen ingested
2)Nutritional intake
Key secondary outcomes Body weight; body mass index (BMI); normalized protein catabolic rate (nPCR); GNRI; serum albumin concentration

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
Food
Interventions/Control_1 Eligible elderly subjects are to be provided with an HD regimen in which the amounts of the component main and side dishes are cut by half and a liquid food (e.g., a soup or broth) is added, instead, for each meal, with the liquid food.
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 Of the institutionalized elderly patients at the annexed elderly nursing home, patients were judged eligible for entry in the study if they had ingested less than 50% of the usual regimen provided and had a geriatric nutritional risk index (GNRI) of less than 91.2 and thus were assumed to be at high nutritional risk.
Key exclusion criteria 1)Patients who had severe complication
2)Patients who are considered inappropriate for participation in this study by the investigator's judgment
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Funakoshi
Organization Nagasaki Kidney Hospital
Division name Department of nephrology
Zip code
Address 5-1 Kouzennmachi, Nagasaki-shi, Nagasaki
TEL 095-824-1101
Email satoshi2754@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Funakoshi
Organization Nagasaki Kidney Hospital
Division name Department of nephrology
Zip code
Address 5-1 Kouzennmachi, Nagasaki-shi, Nagasaki
TEL 095-824-1101
Homepage URL
Email satoshi2754@yahoo.co.jp

Sponsor
Institute Nagasaki Kidney Hospital
Department of nephrology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 08 Month 26 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 Completed
Date of protocol fixation
2012 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 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
2016 Year 08 Month 25 Day
Last modified on
2016 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027383

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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