Low-potassium Content Vegetables in Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: the Recommended Target of Daily Vegetables Intake; Risk of Hyperkalemia

• Registration Number: NCT06428942
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Brief Summary

Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. Thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

Detailed Description

Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Submitted: 2024-05-26
• Study Start: 2024-05-27
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• CKD stage 3b~5, not yet on dialysis
• Age ≥20 years
• Stable doses of medications for 4 weeks
• Serum potassium level: ≥3.5 and < 5.5 mmol/L

Exclusion Criteria

• Anticipated to receive dialysis within 3 month
• Major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection
• Patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders
• Patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study
• Patients with kidney transplants
• Patients who receive immunosuppressant
• Pregnant women or patients who are planning to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of participants who reach the targets of daily vegetable recommended target	8 weeks	Percentage of participants who reach the targets of daily vegetable recommended

Secondary Outcome Measures

Name	Time	Method
Occurrence of moderate hyperkalemia	8 weeks	serum \[potassium\] \>=5.5 mmol/L
Proteinuria	8 weeks	Change in proteinuria in g/day
Gut-derived uremic toxins	8 weeks	Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate)
Serum creatinine	8 weeks	Change in serum creatinine in mg/dL
Status of constipation	8 weeks	Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome.
Gut microbiome	8 weeks	Change in alpha- and beta-diversities indices

Trial Locations

Locations (1)

Taipei Tzu Chi Hospital; 🇨🇳 New Taipei City, Taiwan