Dietary Potassium Liberalization in Pre-Dialysis Patients

NCT05090865 | Recruiting DMC

• 1 other identifier: HS25191 (B2021:104)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

Chronic Kidney Disease; Hyperkalemia

Keywords

Potassium; Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in serum potassium concentrations between treatments

  Serum potassium at the end of the liberalize dietary potassium period compared to the end of restricted dietary potassium period

  between endpoints of each experimental period (week 8 to week 16)

Secondary Outcomes (11)

• Change in physical function related quality of life between treatments

  between endpoints of each experimental period (week 8 to week 16)

• Change in urinary potassium between treatments

  between endpoints of each experimental period (week 8 to week 16)

• Change in urinary sodium between treatments

  between endpoints of each experimental period (week 8 to week 16)

• Urinary albumin to creatinine Ratio

  between endpoints of each experimental period (week 8 to week 16)

• Urinary urea

  between endpoints of each experimental period (week 8 to week 16)

Study Arms (2)

Liberalized dietary potassium and then restricted potassium via fruit and vegetables

OTHER

Participants will receive weekly supplementation of higher potassium fruit and vegetables via grocery home delivery during the liberalized dietary potassium 2-week run-in and liberalized potassium treatment period, then cross-over to the restricted potassium treatment period following a 2-week washout period. Participants will receive a 30-60 minute dietary counseling session in the first week of each treatment period from a registered dietitian (RD), either in person or via videoconference, depending on regional Coronavirus disease (COVID)-19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the fruit and vegetables into the participant's current diet.

Dietary Supplement: Liberalized dietary potassium via fruits and vegetables; Dietary Supplement: Standard dietary potassium restriction

Restricted dietary potassium and then liberalized potassium via fruit and vegetables

OTHER

Participants will receive weekly supplementation of higher potassium fruit and vegetables via grocery home delivery during the liberalized dietary potassium 2 week run-in and then start receiving a restricted potassium treatment period, then cross-over to the liberalized potassium treatment period following a 2-week washout period. Participants will receive a 30-60 minute dietary counseling session in the first week of each treatment period from a registered dietitian (RD), either in person or via videoconference, depending on regional COVID-19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the fruit and vegetables into the participant's current diet

Dietary Supplement: Liberalized dietary potassium via fruits and vegetables; Dietary Supplement: Standard dietary potassium restriction

Interventions

Liberalized dietary potassium via fruits and vegetables DIETARY_SUPPLEMENT

On the liberalized dietary potassium intervention, participants will receive groceries delivered to their houses that contain potassium rich fruit and vegetables, that contain more than 250 mg of potassium per typical serving. Participants will be instructed to incorporate the fruit and vegetables into their diet targeting a daily intake of 2000 mg of potassium a day from delivered fruit and vegetables, and a daily dietary potassium intake of 3500 mg.

Liberalized dietary potassium and then restricted potassium via fruit and vegetables; Restricted dietary potassium and then liberalized potassium via fruit and vegetables

Standard dietary potassium restriction DIETARY_SUPPLEMENT

Participants will receive weekly supplementation of lower potassium fruit and vegetables, that deliver less than 200 mg of potassium per typical serving. Participants will be instructed to incorporate the fruit and vegetables into their diet targeting a daily intake of 500 mg of K a day from the box, and a daily dietary K intake \< 2000 mg. Participants will receive counselling from a registered dietician (RD) to reinforce the potassium restriction.

Liberalized dietary potassium and then restricted potassium via fruit and vegetables; Restricted dietary potassium and then liberalized potassium via fruit and vegetables

Eligibility Criteria

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

You may qualify if:

• 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 \&lt;160/100 mmHg
• Are registered in the multidisciplinary nephrology clinic in Winnipeg
• Able to communicate in English and provide written informed consent

You may not qualify if:

• Serum potassium concentration \&gt; 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

Sponsors & Collaborators

• University of Manitoba: lead
• Dalhousie University: collaborator

Study Sites (2)

Seven Oaks General Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, R2V 3M3, Canada

RECRUITING

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Related Publications (1)

• Iman Y, Balshaw R, Alexiuk M, Hingwala J, Cahill L, Mollard R, Tangri N, Mackay D. Dietary potassium liberalization with fruit and vegetables versus potassium restriction in people with chronic kidney disease (DK-Lib CKD): a clinical trial protocol. BMC Nephrol. 2023 Oct 13;24(1):301. doi: 10.1186/s12882-023-03354-4.

  PMID: 37833679 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Interventions

Vegetables

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dylan Mackay, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dylan Mackay, PhD

CONTACT

2042723119; dylan.mackay@umanitoba.ca

Rebecca Mollard, PhD

CONTACT

rmollard@sogh.mb.ca

Study Design

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

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: January 15, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will become available following the publication of the primary results manuscript.
• Access Criteria: De-identified IPD may also be requested from the principle investigator upon reasonable request.

Locations

CA (2)