Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis

NCT07772856 | Not Yet Recruiting DMC

• 2 other identifiers: UOntarioIT1231588293
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Kidney Disease (ESKD); Hemodialysis; Diet Intervention; Hyperkalemia; Potassium Bioavailability

Keywords

end stage kidney disease; hemodialysis; diet intervention; hyperkalemia; potassium bioavailability

Outcome Measures

Primary Outcomes (1)

• Time-averaged serum potassium

  Time-averaged serum potassium is calculated as the mean of all weekly serum potassium measurements (mmol/L) for a participant over the defined study period, providing an integrated measure of potassium exposure over time and reducing the influence of isolated or transient fluctuations. Time-averaged serum potassium will be calculated as the area under the serum potassium-time curve divided by the total observation time.

  12 weeks

Secondary Outcomes (5)

• Safety - Severe Hyperkalemia

  12 weeks

• Dietary Nutrient Intake

  12 weeks

• Health-Related Quality of Life

  12 weeks

• Diet Quality

  12 weeks

• Ultra-processed food consumption

  12 weeks

Other Outcomes (1)

• Barriers and Facilitators to Adoption of Dietary Intervention

  12 weeks

Study Arms (2)

Liberalized Potassium Diet

EXPERIMENTAL

The intervention arm will liberalize their potassium intake to include fruits, vegetables, whole grains, nuts and legumes to achieve a daily potassium intake of \~2600-3000 mg per day.

Behavioral: Liberalized Potassium Diet

Low Potassium Diet

ACTIVE COMPARATOR

The control group will limit higher potassium fruits, vegetables, juices, and grains, to achieve a potassium intake of \~2000 mg/day.

Behavioral: Low Potassium Diet

Interventions

Liberalized Potassium Diet BEHAVIORAL

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.

Liberalized Potassium Diet

Low Potassium Diet BEHAVIORAL

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.

Low Potassium Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years on maintenance HD \>3 months
• ≥1 serum potassium concentration \>5.0 mmol/L on routine bloodwork in past 12 months
• Able to provide consent

You may not qualify if:

• Treatment with potassium binders within the preceding 7 days
• Average Urea reduction rate over the past 3 months \<65%
• \>2 missed scheduled dialysis sessions in the previous month
• Patients receiving \<3 hemodialysis sessions per week (ex/ incremental dialysis)
• Average serum potassium concentration \>6.0 mmol/L over the past 3 months
• Swallowing difficulties or other GI issues preventing adequate intake
• Residing in an institutional setting (e.g., Long-term care homes) where meals are provided
• HbA1c \>11%
• Unable to comply with study procedures due to cognitive impairment, language barrier or for any additional reason specified by the attending clinician

Sponsors & Collaborators

• Unity Health Toronto: collaborator
• University of Ontario Institute of Technology: lead

Study Sites (1)

St. Michael's Hospital (Unity Health Toronto)

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperkalemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ron Wald, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• JoAnne Arcand, PhD, RD

  University of Ontario Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JoAnne Arcand, PhD, RD

CONTACT

905-721-8668; JoAnne.Arcand@ontariotechu.ca

Arti Sharma Parpia, MSc, RD

CONTACT

416-864-5228; Arti.Parpia@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 19, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

CA (1)