UMIN-CTR Clinical Trial

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
Last 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
Email	hoso9582@med.niigata-u.ac.jp

Public contact
1st 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
Email	hoso9582@med.niigata-u.ac.jp

Sponsor
Institute	Department of Clinical Nutrition Science, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018169