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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030092
Receipt No. R000034356
Scientific Title Nutritional assessment of patients with chronic kidney disease
Date of disclosure of the study information 2017/11/23
Last modified on 2019/10/30

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Basic information
Public title Nutritional assessment of patients with chronic kidney disease
Acronym Nutritional assessment of patients with chronic kidney disease
Scientific Title Nutritional assessment of patients with chronic kidney disease
Scientific Title:Acronym Nutritional assessment of patients with chronic kidney disease
Region
Japan

Condition
Condition Chronic kidney disease(CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the nutritional status of CKD patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the nutritional status of CKD patients using Brief-type self-administered Diet History Questionnaire (BDHQ) and Bio-electrical Impedance Analysis (BIA)
Key secondary outcomes To evaluate the exercise capacity of CKD patients by grip strength and chair-stand test

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
95 years-old >=
Gender Male and Female
Key inclusion criteria CKD patients with stage G3a or more
Key exclusion criteria Patients complicated with serious diseases such as malignancy, heart failure (NYHA III degrees or more), and liver cirrhosis
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Michio
Middle name
Last name Kuwahara
Organization Saitama Tsukinomori Clinic
Division name Division of Nephrology
Zip code 339-0012
Address 366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL 048-792-1811
Email kuwahara@k-naika-cl.jp

Public contact
Name of contact person
1st name Megumi
Middle name
Last name Kobayashi
Organization Saitama Tsukinomori Clinic
Division name Division of Nutrition
Zip code 339-0012
Address 366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
TEL 048-792-1811
Homepage URL
Email Kobayashi.megumi@k-naika-cl.jp

Sponsor
Institute Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization Saitama Tsukinomori Clinic
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 committee of Saitama Tsukinomori Clinic
Address 366-1 Masunaga, Iwatsuki-ku, Saitama City, Saitama 339-0012, Japan
Tel 0487921811
Email hayama@k-naika-cl.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
2017 Year 11 Month 23 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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 04 Month 01 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The subject of this observational study is all of our clinic patients that fulfilled the inclusion criteria of the study. Enrolled patients are estimated protein and salt intake by BDHQ. Furthermore, body water content, muscle mass, mineral amount, and body fat mass are evaluated using InBody (InBody Japan Inc., Tokyo), a body composition analyzer.

Management information
Registered date
2017 Year 11 Month 23 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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