UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015630 |
|---|---|
| Receipt number | R000018169 |
| Scientific Title | Randomized, multicenter, controlled study for the efficacy of low-protein rice diet in patients with chronic kidney disease |
| Date of disclosure of the study information | 2014/11/11 |
| Last modified on | 2019/03/31 09:46:07 |
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Basic information
Public title
Randomized, multicenter, controlled study for the efficacy of low-protein rice diet in patients with chronic kidney disease
Acronym
RICE study
Scientific Title
Randomized, multicenter, controlled study for the efficacy of low-protein rice diet in patients with chronic kidney disease
Scientific Title:Acronym
RICE study
Region
| Japan |
Condition
Condition
Chronic kidney disease (CKD)
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of low-protein rice in protein restriction diet therapy for patients with CKD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Covariance analysis of estimated protein intake per standard weight, adjusted by the intake at the start of the study
Key secondary outcomes
1) Change of estimated energy intake
2) Change of renal functional parameters
3) Change of clinical nutritional parameters related to the criteria of protein energy wasting (PEW)
4) Change of parameters for phosphorus metabolism and metabolic acidosis
5) Change of parameters of quality of life (QOL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Protein restriction diet therapy (0.7 g/kg standard body weight/day) with low-protein rice for 24 weeks
Interventions/Control_2
Protein restriction diet therapy (0.7 g/kg standard body weight/day) without low-protein rice or any other low-protein foods for 24 weeks
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
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1) CKD stages from G3aA2 to G4 in the KDIGO category
2) Those who have not used low-protein foods for the past one year
3) Body mass index of >20 and <27 kg/m2
4) Outpatients
5) Those at the age of 20 to 75
6) Those who have given written informed consent on the use of their data for the study
Key exclusion criteria
1) Those with nephrotic syndrome
2) Those with polycystic kidney disease
3) Those with severe heart or liver disease
4) Those with pregnancy or at breast feeding
5) Those who are considered not eligible for the study by attending doctors due to any medical reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Hosojima |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Clinical Nutrition Science
Zip code
950-8520
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL
025-368-9312
hoso9582@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Hosojima |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Clinical Nutrition Science
Zip code
950-8520
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL
025-368-9312
Homepage URL
hoso9582@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Clinical Nutrition Science, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Niigata Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shinrakuen Hospital, Niigata Rinko Hospital, Nagaoka Red Cross Hospital, Nagaoka Chuo General Hospital, Tatchikawa General Hospital, Takeda General Hospital
Name of secondary funder(s)
Kameda Seika Corporation, Biotech Japan Corporation, Foricafoods Corporation, Sato Foods Corporation
IRB Contact (For public release)
Organization
The institutional review boards of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
Tel
025-227-2006
shomu@med.niigata-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
新潟大学医歯学総合病院(新潟県)、信楽園病院(新潟県)、臨港病院（新潟県）、長岡赤十字病院（新潟県）、長岡中央綜合病院（新潟県）、立川綜合病院（新潟県）、竹田綜合病院（福島県）、佐渡総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 11 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 05 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 18 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 07 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018169
