Chronic Kidney DiseaseDK-LIBNCT05090865
Dietary Potassium Liberalization in Pre-Dialysis Patients
A study testing Liberalized dietary potassium via fruits and vegetables and Standard dietary potassium restriction in people with Chronic Kidney Disease and Hyperkalemia, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hyperkalemia
- What is being tested?
- Liberalized dietary potassium via fruits and vegetables and Standard dietary potassium restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Jan 2024to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Seven Oaks General Hospital Chronic Disease Innovation Centre
Winnipeg, Manitoba, R2V 3M3
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Dietary Potassium Liberalization With Fruit and Vegetables Versus Potassium Restriction in People With Chronic Kidney Disease (DK-Lib CKD) 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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Hyperkalemia
- Being tested
- Liberalized dietary potassium via fruits and vegetables, Standard dietary potassium restriction
- Keywords
- Potassium, Nutrition
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberalized dietary potassium via fruits and vegetablesDietary 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 restrictionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Dietary Supplement: Liberalized dietary potassium via fruits and vegetables; Dietary Supplement: Standard dietary potassium restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between endpoints of each experimental period (week 8 to week 16)
Secondary outcomes (11)
Change in physical function related quality of life between treatments
Participants will complete the SF-12 physical component score of the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire.
Measured: between endpoints of each experimental period (week 8 to week 16)
Change in urinary potassium between treatments
total potassium concentration in mmol/L
Measured: between endpoints of each experimental period (week 8 to week 16)
Change in urinary sodium between treatments
Total sodium concentration in mmol/L
Measured: between endpoints of each experimental period (week 8 to week 16)
Urinary albumin to creatinine Ratio
calculated by dividing urinary albumin concentration in milligrams by urinary creatinine concentration in grams
Measured: between endpoints of each experimental period (week 8 to week 16)
Urinary urea
Measured in mmol/L
Measured: between endpoints of each experimental period (week 8 to week 16)
Urinary phosphate
Measured in mmol/L
Measured: between endpoints of each experimental period (week 8 to week 16)
Hemoglobin A1c
Measure of glycosylated hemoglobin, hemoglobin A1c, expressed as a percentage
Measured: between endpoints of each experimental period (week 8 to week 16)
Systolic blood pressure
Blood pressure will be measured in triplicate using a validated blood pressure monitor following Kidney Disease: Improving Global Outcomes (KDIGO) 2021 measurement guidelines, the average of the 2nd and 3rd measurements will be recorded.
Measured: between endpoints of each experimental period (week 8 to week 16)
Diastolic blood pressure
Blood pressure will be measured in triplicate using a validated blood pressure monitor following KDIGO 2021 measurement guidelines, the average of the 2nd and 3rd measurements will be recorded.
Measured: between endpoints of each experimental period (week 8 to week 16)
Five repetition chair stand time
Assessing physical functionality by asking participant to sit with arms folded in a chair and then stand up and sit down 5 times as fast as they can, time to complete is recorded.
Measured: between endpoints of each experimental period (week 8 to week 16)
Dietary Intake
Dietary intake will be captured via triplicate dietary recall surveys using the Automated Self-Administered 24 hours Canada (ASA24, NCI, Rockville, Maryland, USA; http:// asa24. ca/)
Measured: between endpoints of each experimental period (week 8 to week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start15 Jan 2024
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Dylan MacKay, University of Manitoba
- Investigators
- Dylan Mackay, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090865
- Sponsor's protocol ID
- HS25191 (B2021:104)
- Acronym
- DK-LIB
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD)may be placed in a repository if required by a journal for publication purposes. De-identified IPD may also be requested from the principle investigator.
Publications
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.
PubMed 37833679
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Potassium Liberalization With Fruit and Vegetables Versus Potassium Restriction in People With Chronic Kidney Disease (DK-Lib CKD) Trial
- ClinicalTrials.gov ID
- NCT05090865
- Acronym / sponsor ID
- DK-LIB / HS25191 (B2021:104)
- Conditions
- Chronic Kidney Disease, Hyperkalemia
- Keywords
- Potassium, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberalized dietary potassium and then restricted potassium via fruit and vegetables | Other | Dietary Supplement: Liberalized dietary potassium via fruits and vegetables, Dietary Supplement: Standard dietary potassium restrictionParticipants 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. |
| Restricted dietary potassium and then liberalized potassium via fruit and vegetables | Other | Dietary Supplement: Liberalized dietary potassium via fruits and vegetables, Dietary Supplement: Standard dietary potassium restrictionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberalized dietary potassium via fruits and vegetablesOn 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. | Dietary supplement | 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 restrictionParticipants 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. | Dietary supplement | Liberalized dietary potassium and then restricted potassium via fruit and vegetables, Restricted dietary potassium and then liberalized potassium via fruit and vegetables |
Primary outcome
Change in serum potassium concentrations between treatments
Time frame: between endpoints of each experimental period (week 8 to week 16)
Serum potassium at the end of the liberalize dietary potassium period compared to the end of restricted dietary potassium period
11 secondary outcomes
Change in physical function related quality of life between treatments
Time frame: between endpoints of each experimental period (week 8 to week 16)
Change in urinary potassium between treatments
Time frame: between endpoints of each experimental period (week 8 to week 16)
Change in urinary sodium between treatments
Time frame: between endpoints of each experimental period (week 8 to week 16)
Urinary albumin to creatinine Ratio
Time frame: between endpoints of each experimental period (week 8 to week 16)
Urinary urea
Time frame: between endpoints of each experimental period (week 8 to week 16)
Urinary phosphate
Time frame: between endpoints of each experimental period (week 8 to week 16)
Hemoglobin A1c
Time frame: between endpoints of each experimental period (week 8 to week 16)
Systolic blood pressure
Time frame: between endpoints of each experimental period (week 8 to week 16)
Diastolic blood pressure
Time frame: between endpoints of each experimental period (week 8 to week 16)
Five repetition chair stand time
Time frame: between endpoints of each experimental period (week 8 to week 16)
Dietary Intake
Time frame: between endpoints of each experimental period (week 8 to week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 37833679Iman 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD)may be placed in a repository if required by a journal for publication purposes. De-identified IPD may also be requested from the principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Mackay, PhD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberalized dietary potassium via fruits and vegetables and Standard dietary potassium restriction in people with Chronic Kidney Disease and Hyperkalemia, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum potassium concentrations between treatments (time frame: between endpoints of each experimental period (week 8 to week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.