UMIN-CTR Clinical Trial

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
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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
Email	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
Email	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
Email	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
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
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Research case data
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