UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030092 |
|---|---|
| Receipt number | R000034356 |
| Scientific Title | Nutritional assessment of patients with chronic kidney disease |
| Date of disclosure of the study information | 2017/11/23 |
| Last modified on | 2021/11/02 13:24:01 |
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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
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
Kobayashi.megumi@k-naika-cl.jp
Sponsor or person
Institute
Saitama Tsukinomori Clinic
Institute
Department
Personal name
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
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
Terminated
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
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
We have continued to evaluate the nutrition of patients with chronic kidney disease according to the protocol of this study. However, because the dietitian in charge retired, we could not continue the research and had to stop.
Management information
Registered date
| 2017 | Year | 11 | Month | 23 | Day |
Last modified on
| 2021 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
