Ireland
--:--IST
Latest
Clinical Trials in Canada / NCT07772856
Starting soon Not applicable

Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis

NCT07772856 · tracked via the Priya Life Science Canada tracker
Sponsor
University of Ontario Institute of Technology
Phase
Not applicable
Started
2026-08-01
Last updated
2026-08-19

Condition(s) studied

End Stage Kidney Disease (ESKD)HemodialysisDiet InterventionHyperkalemiaPotassium Bioavailability

Investigational drug(s) / intervention(s)

Liberalized Potassium DietLow Potassium Diet

Liberalized Potassium Diet: For 12 weeks, the liberalized potassium diet group (n=74) will increase their intake of minimally processed foods that are higher in potassium, including fruits, vegetables, nuts, legumes and whole grains, while limiting highly processed foods rich in potassium (\>200 mg/serving) and potassium additives. The liberalized diet will provide \~2600-3000. Participants will also be counselled to use cooking techniques to reduce potassium in root vegetables. The liberalized diet will provide \~2600-3000 mg potassium daily, reflecting the mean potassium intake of Canadian adults. Participants will receive weekly individualized counselling (30-60 min) during the first 4 weeks, followed by sessions (weeks 8 \& 12), reflecting usual care and to reinforce adherence. During weeks 1 to 4, weekly home deliveries of groceries will be provided to support early dietary adoption and adherence. During weeks 5-12, participants will receive weekly grocery gift cards to reduce financial barriers and support.

Low Potassium Diet: The control group (n= 74) will limit higher potassium fruits, vegetables, juices, and grains, to achieve a potassium intake of \~2000 mg/day. Participants will also be counselled to use cooking techniques (e.g., double-boiling root vegetables) to reduce potassium. Consistent with standard of care, participants will receive monthly education by a registered dietitian using standardized low potassium education materials that contain lists of foods to 'choose' and 'avoid', and individualized to ensure budget, cooking abilities and patient preferences are addressed, as needed. Participants will receive weekly grocery gift cards for 12 weeks.

Study summary

People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria 1. Age ≥18 years on maintenance HD \>3 months 2. ≥1 serum potassium concentration \>5.0 mmol/L on routine bloodwork in past 12 months 3. Able to provide consent Exclusion Criteria 1. Treatment with potassium binders within the preceding 7 days 2. Average Urea reduction rate over the past 3 months \<65% 3. \>2 missed scheduled dialysis sessions in the previous month 4. Patients receiving \<3 hemodialysis sessions per week (ex/ incremental dialysis) 5. Average serum potassium concentration \>6.0 mmol/L over the past 3 months 6. Swallowing difficulties or other GI issues preventing adequate intake 7. Residing in an institutional setting (e.g., Long-term care homes) where meals are provided 8. HbA1c \>11% 9. Unable to comply with study procedures due to cognitive impairment, language barrier or for any additional reason specified by the attending clinician

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
St. Michael's Hospital (Unity Health Toronto) Toronto Ontario

More University of Ontario Institute of Technology trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07772856 on ClinicalTrials.gov ↗ ← All trials in Canada