Impact of potassium-rich fruits and vegetables on kidney health
Dietary Potassium Liberalization With Fruit and Vegetables Versus Potassium Restriction in People With Chronic Kidney Disease (DK-Lib CKD) Trial
This study is testing whether eating more potassium-rich fruits and vegetables can improve kidney health and overall well-being in people with Chronic Kidney Disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 2 sites (Winnipeg, Manitoba and 1 other locations) |
| Trial ID | NCT05090865 on ClinicalTrials.gov |
What this trial studies
This study investigates how dietary potassium from fruits and vegetables affects serum potassium levels in individuals with Chronic Kidney Disease (CKD). Using a randomized crossover design, participants will receive home deliveries of either high or low potassium fruits and vegetables for 6 weeks each, allowing researchers to assess changes in potassium levels and overall health. Clinical chemistry markers, blood pressure, physical functioning, and quality of life will be monitored throughout the 16-week trial. The goal is to provide evidence that could reshape dietary guidelines for CKD patients regarding potassium intake.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with CKD, specifically those with an estimated glomerular filtration rate between 15 and 45 ml/min/1.73m2 and serum potassium levels between 4.5 and 5.5 mEq/L.
Not a fit: Patients with serum potassium levels above 5.6 mEq/L, those on dialysis, or individuals with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations that enhance the quality of life for patients with CKD.
How similar studies have performed: While dietary potassium restrictions are common in CKD management, this approach of liberalizing potassium intake through fruits and vegetables is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, aged 18 years or above * Participants who have an estimated glomerular filtration rate between 15 and 45 ml/min/1.73m2 * Serum potassium concentration between 4.5 and 5.5 milliequivalent (mEq)/L * Hemoglobin A1c ≤ 11% * Systolic and diastolic blood pressure \<160/100 mmHg * Are registered in the multidisciplinary nephrology clinic in Winnipeg * Able to communicate in English and provide written informed consent Exclusion Criteria: * Serum potassium concentration \> 5.6 mEq/L, anuria, dialysis, or acute kidney injury failure in the 6 months prior to screening * Chronic obstructive pulmonary disease that requires the participant to be on oxygen * New York Heart Association Class 3-4 Heart symptoms or heart, liver or renal transplant * A myocardial infarction or stroke within the last 6 months * Unable to consume study treatments or control, such as swallowing or gastro-intestinal issues * Currently on potassium binding therapy * In the opinion of the investigator any medical condition, uncontrolled systemic disease or concurrent illness that would decrease the study compliance or jeopardize the safety of the participant * Female participant who is pregnant or lactating
Where this trial is running
Winnipeg, Manitoba and 1 other locations
- Seven Oaks General Hospital Chronic Disease Innovation Centre — Winnipeg, Manitoba, Canada (Recruiting)
- Health Sciences Centre — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Principal investigator: Dylan Mackay, PhD — University of Manitoba
- Study coordinator: Dylan Mackay, PhD
- Email: dylan.mackay@umanitoba.ca
- Phone: 2042723119
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.