UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037484 |
|---|---|
| Receipt number | R000042652 |
| Scientific Title | Nutritional assessment methods for evaluating protein-energy wasting of hemodialysis patients. |
| Date of disclosure of the study information | 2019/07/25 |
| Last modified on | 2019/07/25 14:47:43 |
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Basic information
Public title
Nutritional assessment methods for evaluating protein-energy wasting of hemodialysis patients.
Acronym
Nutritional assessment methods for evaluating protein-energy wasting of hemodialysis patients.
Scientific Title
Nutritional assessment methods for evaluating protein-energy wasting of hemodialysis patients.
Scientific Title:Acronym
Nutritional assessment methods for evaluating protein-energy wasting of hemodialysis patients.
Region
| Japan |
Condition
Condition
Chronic Kidney Desease (stage G5D)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Protein-energy wasting(PEW) is common disease in hemodialysis(HD) patients. In general, loss of muscle mass appear on early stage of malnutrition. The object of this study is to examine methods to detect muscle loss early and to establish methods to detect PEW early in HD patients.
Basic objectives2
Others
Basic objectives -Others
MIA syndrome has been proposed in HD patients. Malnutrition is associated with inflammation and arteriosclerosis in HD patients. The object of this study is to examine these relationships.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mid-arm measurements
Key secondary outcomes
1. mid-arm muscle circumference
2. muscle area of the thigh was measured by using X-ray computed tomography
3. parameters of visceral protein pool size
4. nutritional parameters
5. inflammatory parameters
6. abdominal aortic calcification index
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
maintenance hemodialysis patients
Key exclusion criteria
1. Patients with severe inflammation, perioperative period and severe injury.
2. Patients with heart failure, cirrhosis, COPD, nephrotic syndrome and malignancy.
3. Patients who are considered inappropriate for study participation by the examining physician.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | YAMADA |
| Middle name | |
| Last name | Kohsuke |
Organization
Kamakura women's university
Division name
Department of Nutrition and Dietetics
Zip code
247-8512
Address
6-1-3, ohfuna, kamakura city, Kanagawa, 247-8512, Japan.
TEL
0467-44-2111
yamada-cln@umin.net
Public contact
Name of contact person
| 1st name | YAMADA |
| Middle name | |
| Last name | Kohsuke |
Organization
Kamakura women's university
Division name
Department of Nutrition and Dietetics
Zip code
247-8512
Address
6-1-3, ohfuna, kamakura city, Kanagawa, 247-8512, Japan.
TEL
0467-44-2111
Homepage URL
yamada-cln@umin.net
Sponsor or person
Institute
Kamakura women's university
Institute
Department
Personal name
Funding Source
Organization
Kamakura women's university
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
IRB of Kamakura women's university
Address
6-1-3, ohfuna, kamakura city, Kanagawa, 247-8512, Japan.
Tel
0467-44-2111
kwugakuj@kamakura-u.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
| 2019 | Year | 07 | Month | 25 | 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
116
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively observe the nutritional status, inflammation and arteriosclerosis on hemodialysis patients.
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042652
