UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061201 |
|---|---|
| Receipt number | R000070034 |
| Scientific Title | Pilot study on changes in serum potassium levels following intake of low-potassium lettuce in patients with chronic kidney disease |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/04/08 18:50:20 |
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Basic information
Public title
Pilot study on changes in serum potassium levels following intake of low-potassium lettuce in patients with chronic kidney disease
Acronym
Pilot study on changes in serum potassium levels following intake of low-potassium lettuce in patients with chronic kidney disease
Scientific Title
Pilot study on changes in serum potassium levels following intake of low-potassium lettuce in patients with chronic kidney disease
Scientific Title:Acronym
Pilot study on changes in serum potassium levels following intake of low-potassium lettuce in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate whether low-potassium lettuce attenuates increases in serum potassium levels compared with regular lettuce in patients with chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in serum potassium levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low-potassium lettuce
Interventions/Control_2
Normal lettuce
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hospitalized patients with CKD stage 3b-5 (eGFR <45 mL/min/1.73 m2)
2. Patients with serum potassium levels of 4.0-5.5 mEq/L
3. Patients able to take food orally and follow dietary instructions
4. Patients who provided written informed consent to participate in this study
Key exclusion criteria
1. Patients with a history of serum potassium <3.0 mEq/L or >6.0 mEq/L within 6 months before enrollment
2. Patients taking oral potassium supplements
3. Patients taking potassium-binding agents
4. Patients with systolic blood pressure >=180 mmHg or diastolic blood pressure >=120 mmHg
5. Patients with diabetes mellitus requiring insulin therapy or with poor glycemic control (HbA1c >8%)
6. Patients with severe heart failure (ACCF/AHA stage C or D or NYHA class III or IV)
7. Patients with BMI >35 kg/m2
8. Patients whose doses of diuretics, RAS inhibitors, SGLT2 inhibitors, or trimethoprim/sulfamethoxazole were changed within 1 month before enrollment
9. Patients with alcohol dependence or liver cirrhosis
10. Patients with chronic obstructive pulmonary disease requiring oxygen therapy
11. Patients undergoing maintenance dialysis or scheduled to initiate dialysis within 2 weeks
12. Patients with an allergy to lettuce
13. Pregnant or lactating women, or women of childbearing potential
14. Patients taking herbal (Kampo) medicines
15. Patients considered inappropriate for participation in this study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fujii |
| Middle name | |
| Last name | Hideki |
Organization
Kobe University Hospital
Division name
Division of Nephrology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6500
fhideki@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hayaki |
| Middle name | |
| Last name | Okamoto |
Organization
Kobe University Hospital
Division name
Division of Nephrology
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6500
Homepage URL
hayaki.okamoto.0201@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Itoh Denki Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee at Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-6669
kainyu@med.kobe-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070034
