UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027690
Receipt No. R000031335
Scientific Title Effect of protein restricted diet on diet adherence and kidney function using portion control plate in patients with chronic kidney disease: A randomized controlled trial
Date of disclosure of the study information 2017/06/15
Last modified on 2017/09/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of protein restricted diet on diet adherence and kidney function using portion control plate in patients with chronic kidney disease: A randomized controlled trial
Acronym Healthy eating plate CKD trial
Scientific Title Effect of protein restricted diet on diet adherence and kidney function using portion control plate in patients with chronic kidney disease: A randomized controlled trial
Scientific Title:Acronym Healthy eating plate CKD trial
Region
Japan

Condition
Condition Chronic kidney disease (stage: 3-5)
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of a low protein diet on dietary adherence and kidney function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 20% reduction in protein intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Protein restriction using portion control plate
Interventions/Control_2 Conventional therapy
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
64 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age 20-64 years
2) Stage 3-5 CKD
3) A outpatients who is prescribed a protein restricted diet by a physician
Key exclusion criteria 1) Communication disorder that diet therapy can not be understand or cognitive impairment
2) A patient who are not suitable for protein restriction due to conditions such as cancer and AIDS
3) A patient who are unsuitable for continuous low protein diet due to acute renal failure.
4) A patient who are considered to be inappropriate for participation in this trial due to other reason by the physician.
Target sample size 104

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Sakane
Organization Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name Division of Preventive Medicine
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL +81-75-641-9161
Email nsakane@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamauchi Keiko
Organization Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name Division of Preventive Medicine
Zip code
Address 1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL +81-75-641-9161
Homepage URL
Email nsakane@kyotolan.hosp.go.jp

Sponsor
Institute Division of Preventive Medicine, Clinical Research Institute, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 06 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 08 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031335

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.