Clinical trial NCT05090865: Dietary Potassium Liberalization in Pre-Dialysis Patients
Official title: Dietary Potassium Liberalization With Fruit and Vegetables Versus Potassium Restriction in People With Chronic Kidney Disease (DK-Lib CKD) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Hyperkalemia
Keywords: Potassium
Nutrition
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2021-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 with elevated all-cause mortality. To minimize the risk of hyperkalemia, individuals with CKD are told to restrict dietary potassium. This recommendation is based on very-low quality evidence. Dietary potassium restrictions can negatively impact quality of life, and may put participants at risk of nutritional deficiencies so they should be based on good quality evidence. There is a need for high quality randomized controlled trials investigating the impact of dietary potassium modification on serum potassium concentrations in people with CKD.

This trial will evaluate the impact and safety of dietary potassium liberalization using fruit and vegetables on serum potassium concentrations in people with CKD. In this 16-week study, the investigators will test if changing the amount of potassium people with CKD are eating with fruits and vegetables changes the amount of potassium in their blood. The investigators will do this by providing people with fruits and vegetables that are either high or low in potassium for a period of 6 weeks. Then these same participants will be provided with fruits and vegetables that they didn't receive in the first 6 weeks, for an additional 6 weeks in what is called a randomized crossover design. In a randomized crossover design everyone gets both treatments, but the order they get them in is chosen at random, like a coin toss. Thirty participants will be recruited to this study. The investigators will measure blood potassium during the study and see if it changes due to the change in potassium in the fruit and vegetables provided. The investigators think that changing the amount of potassium that participants eat through fruit and vegetables will not lead to a different level of potassium in the participants blood, and that having higher potassium fruit and vegetables in the diet may lead to an increase in the participants quality of life. This study's results could change the dietary recommendation given to people living CKD and potentially allow them to eat a greater variety of food.

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 \&lt;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 \&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

Primary outcomes:
measure: Change in serum potassium concentrations between treatments
timeFrame: between endpoints of each experimental period (week 8 to week 16)
Secondary outcomes:
measure: Change in physical function related quality of life between treatments
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Change in urinary potassium between treatments
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Change in urinary sodium between treatments
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Urinary albumin to creatinine Ratio
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Urinary urea
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Urinary phosphate
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Hemoglobin A1c
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Systolic blood pressure
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Diastolic blood pressure
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Five repetition chair stand time
timeFrame: between endpoints of each experimental period (week 8 to week 16)
measure: Dietary Intake
timeFrame: between endpoints of each experimental period (week 8 to week 16)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Seven Oaks General Hospital Chronic Disease Innovation Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Dylan Mackay, PhD
role: PRINCIPAL_INVESTIGATOR
References: