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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000037484 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Chronic Kidney Desease (stage G5D) | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Kamakura women's university |
Institute | |
Department |
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 |
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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 |
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Other | |
Other related information | We retrospectively observe the nutritional status, inflammation and arteriosclerosis on hemodialysis patients. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042652 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |