Clinical Trial: Pilot study on changes in serum potassium levels following intake of low-potassium lettuce in patients with chronic kidney disease (Japan)

Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061201) titled 'Pilot study on changes in serum potassium levels following intake of low-potassium lettuce in patients with chronic kidney disease' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Kobe University

Condition: Condition - Chronic kidney disease Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Low-potassium lettuce Interventions/Control_2 - Normal lettuce

Eligibility: Age-lower limit - 18 years-old 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 Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 08 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070034

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