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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032234
Receipt No. R000036578
Scientific Title Utility of nutritional intervention for elderly dialysis patients
Date of disclosure of the study information 2018/04/16
Last modified on 2019/09/09

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Basic information
Public title Utility of nutritional intervention for elderly dialysis patients
Acronym Utility of nutritional intervention for elderly dialysis patients
Scientific Title Utility of nutritional intervention for elderly dialysis patients
Scientific Title:Acronym Utility of nutritional intervention for elderly dialysis patients
Region
Japan

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

Objectives
Narrative objectives1 To investigate the Utility of nutritional intervention for elderly dialysis patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Dietary intake
2.Survival rate
Key secondary outcomes 1.Laboratory values
2.Body constituent analysis values
3.Bone density
4.Complication incidence rate
5.Hospitalization rate

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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Nutritional guidance aimed at adequate intake of energy and protein
Interventions/Control_2 In addition to nutritional guidance aimed at adequate intake of energy and protein, nutritional intervention using nutrient supplement etc.
Interventions/Control_3 Conventional treatment
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.Dialysis patients over 65 years old
2.As a result of meal survey, patients who do not meet energy and protein requirements
Key exclusion criteria 1.Patients who are difficult to communicate
2.Patients judged inappropriate by the research director
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kyoko
Middle name
Last name Mori
Organization Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name Department of Nutrition management
Zip code 770-8548
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL 088-631-0110
Email k.mori@khg.or.jp

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Mori
Organization Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Division name Department of Nutrition management
Zip code 770-8548
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
TEL 088-631-0110
Homepage URL
Email k.mori@khg.or.jp

Sponsor
Institute Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
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 Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Address 1-1-39 Kitasako, Tokushima, 770-8548, Japan
Tel 088-631-0110
Email sasaka@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 社会医療法人川島会 川島透析クリニック(徳島県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 16 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 06 Day
Date of IRB
2018 Year 03 Month 06 Day
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 13 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036578

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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