Status:
RECRUITING
Dietary Potassium Liberalization in Pre-Dialysis Patients
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Dalhousie University
Conditions:
Chronic Kidney Disease
Hyperkalemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. ...
Detailed Description
The kidney is a primary site of potassium regulation in the body. Hyperkalemia, elevated serum potassium, occurs in approximately 10% of patients with chronic kidney disease (CKD) and is associated wi...
Eligibility 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
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05090865
Start Date
January 15 2024
End Date
May 31 2026
Last Update
January 16 2026
Active Locations (2)
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1
Seven Oaks General Hospital Chronic Disease Innovation Centre
Winnipeg, Manitoba, Canada, R2V 3M3
2
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9