UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013058 |
|---|---|
| Receipt number | R000015235 |
| Scientific Title | Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2016/09/03 13:40:12 |
* 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
Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients
Acronym
Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients
Scientific Title
Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients
Scientific Title:Acronym
Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients
Region
| Japan |
Condition
Condition
CKD/ESRD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Advanced-stage renal disease patients have potassium restriction on their diet. Therefore, low-potassium lettuce which can be consumed raw by these patients has been developed. The low-potassium lettuce made possible by novel cultivation method is likely safe for end-stage renal disease patients including those on dialysis. Moreover, the low-potassium lettuce maintains the nutritional value for elements other than potassium. Therefore, the consumption of low-potassium lettuce may inhibit the advancement of atherosclerosis and renal function deterioration. However, clinical evidence is still lacking. The aim of this clinical study is to examine the safety and efficacy of low-potassium lettuce.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum potassium
Key secondary outcomes
Total protein, albumin, blood urea nitrogen, creatinine, sodium, chloride, calcium, phosphate, magnesium, zinc, vitamin A, B1, B2, C, E, high-sensitivity C-reactive protein
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low-potassium lettuce
20 g to 40 g/1 dish
6 dishes/2 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
Adult human undergoing chronic dialysis therapy
Key exclusion criteria
Pregnant
History of hyperkalemia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Yatabe |
Organization
Fukushima Medical University
Division name
Department of Chronic Kidney Disease Initiatives
Zip code
Address
1 Hikarigaoka, Fukushima, Japan, 960-1295
TEL
024-547-1206
jyatabe@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Yatabe |
Organization
Fukushima Medical University
Division name
Department of Chronic Kidney Disease Initiatives
Zip code
Address
1 Hikarigaoka, Fukushima, Japan, 960-1295
TEL
024-547-1206
Homepage URL
jyatabe@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
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
社団医療法人養生会 かしま病院
Kashima Hospital
医療法人 かもめクリニック
Kamome Clinic
医療法人 ニュータウン腎・内科クリニック
Newtown Nephro Medical Clinic
援腎会 すずきクリニック
En-Jin-Kai Suzuki Clinic
福島県厚生農業協同組合連合会 坂下厚生総合病院
Bange Kousei General Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 03 | 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
| 2013 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2016 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015235
