UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032234 |
|---|---|
| Receipt number | R000036578 |
| Scientific Title | Utility of nutritional intervention for elderly dialysis patients |
| Date of disclosure of the study information | 2018/04/16 |
| Last modified on | 2022/07/26 10:55:40 |
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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
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
k.mori@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital, Social Medical Corporation Kawashima Hospital Group
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
159
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
| 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
| 2022 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036578
