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Electrolyte Supplement

Dietary Potassium Liberalization for Chronic Kidney Disease (DK-LIB Trial)

N/A

Recruiting

Led By Dylan Mackay, PhD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who have an estimated glomerular filtration rate between 15 and 45 ml/min/1.73m2

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of different potassium levels in fruits and vegetables on people with Chronic Kidney Disease. It will measure things like blood pressure and quality of life. The results could change dietary recommendations for people with CKD.

Who is the study for?

This trial is for English-speaking adults over 18 with Chronic Kidney Disease, who are not on dialysis but have a certain level of kidney function and controlled blood sugar. They should have slightly elevated potassium levels but not be in advanced heart failure, recently had a heart attack or stroke, or have severe lung disease requiring oxygen.

What is being tested?

The study tests if eating fruits and vegetables with different amounts of potassium affects blood potassium levels in CKD patients. It's a randomized crossover trial where participants will get home deliveries of these foods to include in their diet and then switch after some time.

What are the potential side effects?

Since the intervention involves dietary changes rather than medication, side effects may be minimal but could include changes in blood pressure or digestive discomfort due to increased fruit and vegetable intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by filtration rate, is low but not extremely low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had serious kidney issues or very high potassium levels in the last 6 months.

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I have COPD and need oxygen therapy.

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I am currently pregnant or breastfeeding.

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I cannot swallow pills or have stomach issues that prevent me from taking certain medications.

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I have severe heart failure symptoms or have had a heart, liver, or kidney transplant.

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I am currently taking medication to control my potassium levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and between endpoints of each experimental period (week 8 to week 16) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in serum potassium concentrations between treatments

Secondary study objectives

Change in physical function related quality of life between treatments

Change in urinary potassium between treatments

Change in urinary sodium between treatments

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Restricted dietary potassium and then liberalized potassium via fruit and vegetablesExperimental Treatment2 Interventions

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

Group II: Liberalized dietary potassium and then restricted potassium via fruit and vegetablesExperimental Treatment2 Interventions

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.

0 / 7Eligibility criteria met