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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009784
Receipt No. R000011092
Scientific Title Evaluating validity of dietary salt intake assessment: Dietary survey among Japanese Hemodialysis patients
Date of disclosure of the study information 2013/01/21
Last modified on 2016/01/18

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Basic information
Public title Evaluating validity of dietary salt intake assessment: Dietary survey among Japanese Hemodialysis patients
Acronym Dietary salt intake assessment in HD patients
Scientific Title Evaluating validity of dietary salt intake assessment: Dietary survey among Japanese Hemodialysis patients
Scientific Title:Acronym Dietary salt intake assessment in HD patients
Region
Japan

Condition
Condition Chronic kidney disease on maintenance hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Survey accurate dietary sodium intake and demonstrate predictive formula in japanese maintenance hemodialysis patients


Basic objectives2 Others
Basic objectives -Others validation
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes dietary sodium intake
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria maintenance hemodialysis stable patients
age>20 yr
Key exclusion criteria exclude infection, GI trouble, malignancy, acute phase of CVA patients
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyomi Koike
Organization Department of Medicine, Kurume University School of Medicine
Division name Divisions of Nephrology
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011
TEL 0942-35-3311(5346)
Email koike_kiyomi@kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyomi Koike
Organization Department of Medicine, Kurume University School of Medicine
Division name Divisions of Nephrology
Zip code
Address Asahi-machi,67, Kurume, Fukuoka, Japan
TEL 0942-35-3311
Homepage URL
Email koike_kiyomi@kurume-u.ac.jp

Sponsor
Institute Divisions of Nephrology, Department of Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization Japanese Association of Dialysis Physicians
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
Address
Tel
Email

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
2013 Year 01 Month 21 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
2013 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Follow up the patients survival and nutrition status.

Management information
Registered date
2013 Year 01 Month 15 Day
Last modified on
2016 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011092

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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