UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063024 |
|---|---|
| Receipt number | R000072147 |
| Scientific Title | Nutritional intake and dietary pattern on dialysis day and non-dialysis day in patients undergoing hemodialysis. |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/23 11:35:59 |
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Basic information
Public title
Nutritional intake and dietary pattern on dialysis day and non-dialysis day in patients undergoing hemodialysis.
Acronym
Nutritional intake and dietary pattern on dialysis day and non-dialysis day in patients undergoing hemodialysis.
Scientific Title
Nutritional intake and dietary pattern on dialysis day and non-dialysis day in patients undergoing hemodialysis.
Scientific Title:Acronym
Nutritional intake and dietary pattern on dialysis day and non-dialysis day in patients undergoing hemodialysis.
Region
| Japan |
Condition
Condition
End-stage kidney disease
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare the nutritional intake and dietary patterns of hemodialysis patients in Japan between dialysis and non-dialysis days.
Basic objectives2
Others
Basic objectives -Others
The hypothesis of this study was that energy intake in patients undergoing hemodialysis is lower on dialysis days than on non-dialysis days.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in energy intake between dialysis and non-dialysis days.
Key secondary outcomes
The intake of protein, lipid, n-3 polyunsaturated fatty acids, n-6 polyunsaturated fatty acids, carbohydrate, dietary fiber, alcohol, potassium, calcium, magnesium, phosphorus, iron, zinc, copper, manganese, vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, niacin, vitamin B6, vitamin B12, folic acid, pantothenic acid, vitamin C, and the frequency of consumption of each food on dialysis and non-dialysis days.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 years or older
2. Individuals with at least 1 year of dialysis vintage
3. Outpatients undergoing dialysis (hemodialysis or hemodiafiltration) with three times a week
Key exclusion criteria
1. A dialysis sessions are less than 4 hours or 6 hours or longer each time
2. Residence in facilities with meal servise
3. Combined peritoneal dialysis
4. Ongoing treatment for malignant neoplasms
5. Difficulty reading or writing due to impaired cognitive function.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kou |
| Middle name | |
| Last name | Kitabayashi |
Organization
Shinkohkai Murakami Kinen Hospital
Division name
Department of Nutrition
Zip code
958-0034
Address
204-1, matuyama, Murakami-si, Niigata, Japan
TEL
0254-52-1229
whm13002@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kou |
| Middle name | |
| Last name | Kitabayashi |
Organization
Shinkoukai Murakami Kinen Hospital
Division name
Department of Nutrition
Zip code
958-0034
Address
204-1, matuyama, Murakami-si, Niigata, Japan
TEL
0254-52-1229
Homepage URL
whm13002@nuhw.ac.jp
Sponsor or person
Institute
Shinkohkai Murakami Kinen Hospital
Department of Nutrition
Kitabayashi Kou
Institute
Department
Personal name
Kitabayashi Kou
Funding Source
Organization
Grant: Nakatani Suzuyo Memorial Fund for the Promotion of Nutrition Improvement Activities 2026
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
The ethics committees of Shinkohkai Murakami Kinen Hospital
Address
204-1, matuyama, Murakami-si, Niigata, Japan
Tel
0254-52-1229
whm13002@nuhw.ac.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
| 2026 | Year | 11 | Month | 01 | 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
| 2026 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 05 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000072147
