UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005447 |
|---|---|
| Receipt number | R000006463 |
| Scientific Title | Evaluation of dietary intake in hemodialysis patients |
| Date of disclosure of the study information | 2011/04/15 |
| Last modified on | 2019/10/20 12:55:28 |
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Basic information
Public title
Evaluation of dietary intake in hemodialysis patients
Acronym
Evaluation of dietary intake in hemodialysis patients
Scientific Title
Evaluation of dietary intake in hemodialysis patients
Scientific Title:Acronym
Evaluation of dietary intake in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish accuracy evaluation of dietary intake in hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
dietary energy intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
detailed record of dietary intake
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatient in dialysis clinics
Key exclusion criteria
patient who had received dialysis within two years
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Tsukuba
Division name
Department of nephrology
Zip code
305-8575
Address
1-1-1,Ten-nodai, Tsukuba, Ibaraki
TEL
029-853-3202
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Saito |
Organization
University of Tsukuba
Division name
Department of nephrology
Zip code
305-8575
Address
1-1-1,Ten-nodai, Tsukuba, Ibaraki
TEL
029-853-3202
Homepage URL
chie.saito@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of nephrology, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Nonprofit Organization
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
University of Tsukuba
Address
2-1-1,Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
筑波大学腎臓内科
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 15 | 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
50
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data analysing
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
| 2010 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006463
