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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Page 1 of 1 (2 locations)

1

Seven Oaks General Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, Canada, R2V 3M3

2

Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A 1R9