UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009784 |
|---|---|
| Receipt number | 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 11:22:39 |
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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)
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
koike_kiyomi@kurume-u.ac.jp
Sponsor or person
Institute
Divisions of Nephrology, Department of Medicine, Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011092
