UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027690 |
|---|---|
| Receipt number | 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 13:03:40 |
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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
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
nsakane@kyotolan.hosp.go.jp
Sponsor or person
Institute
Division of Preventive Medicine, Clinical Research Institute, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031335
