Dietary Potassium Liberalization in Pre-Dialysis Patients
Canada30 participantsStarted 2024-01-15
Plain-language summary
The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design. Participants will receive home delivery of fruit and vegetables with either higher or lower potassium content in a random order. Clinical chemistry markers from blood and urine samples, blood pressure, physical functioning and health related quality of life will be assessed throughout the duration of the trial. This study will also measure their physical functioning, using a chair stand test. The results of this study could change the dietary recommendations for people with CKD related to potassium.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum potassium concentrations between treatments
Timeframe: between endpoints of each experimental period (week 8 to week 16)