UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038751 |
|---|---|
| Receipt number | R000044133 |
| Scientific Title | Efficacy of digestible protein-restricted rice for chronic kidney disease |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2023/12/05 10:29:33 |
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Basic information
Public title
Study of medical usefulness of rice original variety in Ehime for kidney disease
Acronym
OERC (Original Ehime Rice for CKD) study
Scientific Title
Efficacy of digestible protein-restricted rice for chronic kidney disease
Scientific Title:Acronym
OERC (Original Ehime Rice for CKD) study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using easily digestible protein-restricted rice (treated rice) it easier to limit protein intake in patients with chronic kidney disease, especially patients with chronic renal failure, verifying that uremic substances can be reduced and that deterioration of renal function can be suppressed over the long term Do
Basic objectives2
Others
Basic objectives -Others
Easily digested protein-restricted rice (treated rice) verifies that it has the same taste as plain rice
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In short-term trials, whether treatment rice reduces the decrease in urea substances in CKD patients or in long-term trials suppresses renal function deterioration
Key secondary outcomes
Verify that treatment rice can be ingested for long time
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Use of treated rice
Interventions/Control_2
Use of usual rice
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CKD patients with estimated eGFR 15-45mL/min/1.72m2
Key exclusion criteria
Patients who have difficulty in obtaining informed consent and patients do not agree
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TAKAFUMI |
| Middle name | |
| Last name | OKURA |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Community and Emergency Medicine
Zip code
7910295
Address
Shitsukawa, Toon, Ehime
TEL
+81-89-960-5540
okura@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKAFUMI |
| Middle name | OKURA |
| Last name | OKURA |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Community and Emergency Medicine
Zip code
7910295
Address
Shitsukawa, Toon, Ehime
TEL
+81-89-960-5540
Homepage URL
okura@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Community and Emergency Medicine, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ehime Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-964-5111
okura@m.ehime-u.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
愛媛大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
no releasing URL
Publication of results
Partially published
Result
URL related to results and publications
Ehime Igaku 41; 87-91, 2002
Number of participants that the trial has enrolled
42
Results
The study compared the urinary urea nitrogen/creatinine ratio (UUN/UCr) and blood urea nitrogen/creatinine ratio (BUN/Cr) as the difference of protein intake between the two groups. The results showed no significant differences in protein intake between the two groups (UUN/UCr P=0.78, BUN/Cr P=0.79).
Results date posted
| 2023 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study employed a double-blind crossover design, with one group consuming easily digestible protein rice for the initial four weeks followed by regular rice for the subsequent four weeks, and another group consuming regular rice initially followed by easily digestible protein rice for the next four weeks.
Participant flow
The study compared the urinary urea nitrogen/creatinine ratio (UUN/UCr) and blood urea nitrogen/creatinine ratio (BUN/Cr) as the difference of protein intake between the two groups.
Adverse events
No adverse events
Outcome measures
The results showed no significant differences in protein intake between the two groups (UUN/UCr P=0.78, BUN/Cr P=0.79).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2019 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044133
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