UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039214 |
|---|---|
| Receipt number | 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 | 2023/07/26 15:38:09 |
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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
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
k.iwasa@khg.or.jp
Sponsor or person
Institute
Kawashima-kai, a social medical corporation Kawashima Hospital
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000044691
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000044691
Number of participants that the trial has enrolled
68
Results
Elderly patients with sarcopenia had adequate protein intake but low SMI.
It was suggested that nutritional screening by GNRI and NRI-JH is necessary in addition to protein intake in nutritional guidance for elderly patients.
The sarcopenia group had a significantly lower BMI and no weight gain or loss over the past 5 years, suggesting the need for nutritional guidance to prevent underweight.
Results date posted
| 2023 | Year | 07 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Outpatient hemodialysis patients aged 65 years or older with dialysis history of 2 years or longer (42 males, 26 females)
Participant flow
Evaluation of sarcopenia: Extremity muscle mass, grip strength, five-time chair rise test by bioelectrical impedance method (Inbody Japan Co., Ltd. InbodyS10)
Nutrition index: GNRI (Geriatric Nutritional Risk Index), NRI-JH (nutritional risk index for Japanese hemodialysis patients)
Dietary intake status: Calculation of intake and number of meals for each nutrient and food group based on meal records for 3 days (1 day for dialysis, 2 days for non-dialysis)
Required nutrients are calculated by standard weight (kg) x physical activity (kcal)
Adverse events
none
Outcome measures
Evaluation of sarcopenia: Extremity muscle mass, grip strength, five-time chair rise test by bioelectrical impedance method (Inbody Japan Co., Ltd. InbodyS10)
Nutrition index: GNRI (Geriatric Nutritional Risk Index), NRI-JH (nutritional risk index for Japanese hemodialysis patients)
Dietary intake status: Calculation of intake and number of meals for each nutrient and food group based on meal records for 3 days (1 day for dialysis, 2 days for non-dialysis)
Required nutrients are calculated by standard weight (kg) x physical activity (kcal)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 07 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | 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=R000044691
