Providing low-potassium vegetables to patients with chronic kidney disease
Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial
This study tests if providing low-potassium vegetables can help people with chronic kidney disease eat more veggies without raising their potassium levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 20 Years to 99 Years |
| Sex | All |
| Sponsor | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Academic / other |
| Locations | 2 sites (New Taipei City and 1 other locations) |
| Trial ID | NCT06428942 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of providing low-potassium content vegetables to patients with chronic kidney disease (CKD) stages 3 to 5 who are not yet on dialysis. The goal is to determine if this intervention can help these patients meet the recommended daily intake of vegetables without increasing the risk of hyperkalemia. Previous observational studies suggest that higher vegetable and fruit consumption is linked to lower mortality rates in CKD patients, yet many do not consume adequate amounts. The study will monitor participants' vegetable intake and potassium levels over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with CKD stages 3b to 5 who are not on dialysis and have stable potassium levels.
Not a fit: Patients who are anticipated to start dialysis within three months or have major gastrointestinal diseases or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve dietary habits in CKD patients, potentially leading to better health outcomes and reduced mortality risk.
How similar studies have performed: While there have been observational studies linking vegetable intake to improved outcomes in CKD, this specific intervention with low-potassium vegetables is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Taipei City and 1 other locations
- Taipei Tzu Chi Hospital — New Taipei City, Taiwan (Recruiting)
- Taipei Tzu Chi Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Szu-Chun Hung, MD — Taichung Tzu Chi Hospital
- Study coordinator: TIng-Yun Lin, MD
- Email: water_h2o_6@hotmail.com
- Phone: 886-266289779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.