Dietary Potassium Liberalization in Pre-Dialysis Patients

ConditionsChronic Kidney Disease Hyperkalemia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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.
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Liberalized dietary potassium and then restricted potassium via fruit and vegetablesOther 2 interventions

Group B: Restricted dietary potassium and then liberalized potassium via fruit and vegetablesOther 2 interventions

Trial outcomes

Primary outcomes

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

Time frame