Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063213) titled 'Effects of Low-Potassium Lettuce Intake on Serum Potassium Levels in Patients with Chronic Kidney Disease: A Clinical Study' on Oct. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - Kurume University School of Medicine

Condition: Condition - Hyperkalemia in patients with chronic kidney disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the effects of low-potassium lettuce intake on serum potassium levels and safety outcomes in patients with chronic kidney disease. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants consume 100 g of low-potassium lettuce once daily during the intervention period (Trial 1: 4 days; Trial 2: during the interdialytic interval). The lettuce is consumed raw, and no additional dietary restrictions are imposed beyond routine clinical guidance. Interventions/Control_2 - Participants consume 100 g of standard lettuce once daily during the intervention period (Trial 1: 4 days; Trial 2: during the interdialytic interval). The lettuce is consumed raw in the same manner as the intervention group.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Adults aged 20 years or older with chronic kidney disease (Trial 1) or undergoing maintenance hemodialysis (Trial 2) Ability to provide written informed consent Stable clinical condition with serum potassium levels deemed acceptable for study participation by the treating physician Key exclusion criteria - Severe hyperkalemia or any condition judged by the treating physician to make study participation unsafe Acute illness, active infection, or clinically unstable conditions requiring hospitalization Inability to collect accurate 24hour urine samples (Trial 1 only) Known food allergies or other conditions that prevent lettuce consumption Inability to provide written informed consent Target Size - 40

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2016 Year 08 Month 23 Day Date of IRB - 2016 Year 08 Month 23 Day Anticipated trial start date - 2016 Year 08 Month 23 Day Last follow-up date - 2017 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069615

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