Low-potassium Content Vegetables in Chronic Kidney Disease (LPV in CKD)

Buddhist Tzu Chi Medical Foundation

Status: Enrolling

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

Treatments: Other: low-potassium vegetables

Study type: Interventional

Funder types: Other

Identifiers

NCT06428942

12-XD-093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Intervention group

Experimental group

Description:

The participants in the intervention group would receive their daily low-potassium vegetables 3 to 5 serving according to their daily suggested requirement and routine CKD dietary education for 8 weeks.

Treatment:

Other: low-potassium vegetables

Control group

No Intervention group

Description:

The participants in the control group would receive routine CKD dietary education for 8 weeks.