Dietary Potassium Liberalization in Pre-Dialysis Patients
Recruiting · NCT05090865 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Manitoba
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 it is running
2 locations listed.
- Seven Oaks General Hospital Chronic Disease Innovation Centre - Winnipeg, Manitoba, Canada
- Health Sciences Centre - Winnipeg, Manitoba, Canada