Chronic Kidney DiseasesReDACKDNCT05113641
Reducing Dietary Acid With Food Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD)
A study testing Alkalizing Fruit and Vegetables and Sodium bicarbonate in people with Chronic Kidney Diseases and Metabolic Acidosis, run by Dylan MacKay at 2 sites in Canada.
Trial summary
Metabolic acidosis is a common problem that occurs with worsening chronic kidney disease. Dietary acid can build up when the kidneys are not working well. This can be associated with a higher risk of worsening kidney function and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Metabolic Acidosis
- What is being tested?
- Alkalizing Fruit and Vegetables and Sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Aug 2023to 24 Sep 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
- Participant is willing and able to give informed consent for participation in the trial
- Male or Female, aged 18 years or above
- Participants who have an eGFR between 15 and 40 ml/min/1.73m2
- Two consecutive measurements of serum bicarbonate of 14 to 22 mEq/L
- Systolic and diastolic blood pressure <160/100 mmHg
- Serum potassium <5.3 mmol/L
Show all 9Show fewer
- Hemoglobin A1c below ≤ 11%
- Are registered in the nephrology clinic in Winnipeg or Halifax
- Participants are able to communicate in English and provide written informed consent
Who cannot join
- Anuria, dialysis or acute kidney injury/acute kidney failure in the 3 months prior to screening
- Chronic obstructive pulmonary disease that requires the participant to be on oxygen
- New York Heart Association Class 3-4 Heart failure 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 GI issues
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks
- Currently on potassium binding therapy
- Female participant who is pregnant or on lactating
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Chronic Kidney Disease (Renal) ClinicQEII - Dickson Building
Halifax, Nova Scotia, B3H 2Y9
Seven Oaks General Hospital Chronic Disease Innovation Centre
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) Feasibility Trial
Metabolic acidosis is a common problem that occurs with worsening chronic kidney disease. Dietary acid can build up when the kidneys are not working well. This can be associated with a higher risk of worsening kidney function and death. The usual treatment is a medication called sodium bicarbonate which works to balance the acids in the body. The medication however often does not work and causes side effects. Consumption of alkalizing fruit and vegetables may work as a treatment for metabolic acidosis. This trial is being done to see if fruit and vegetables, provided via home delivery, can become a viable management for metabolic acidosis in patients with chronic kidney disease.
Read the detailed description
Metabolic acidosis is a common complication of advanced chronic kidney disease (CKD). As kidney function declines, the ability to excrete excess dietary acid is reduced. This can lead to the development of metabolic acidosis, an imbalance in the body's acid-base balance. Metabolic acidosis is associated with a higher risk of CKD progression and mortality. Typical treatment includes an oral alkali, such as sodium citrate or sodium bicarbonate. Recent studies have shown that the treatment of metabolic acidosis can reduce the decline in kidney function and potentially prevent progression of CKD to dialysis. Treatment rates with an oral alkali are low because the treatments are ineffective, often poorly tolerated, and may be associated with net harm. Base producing fruit and vegetables are a potential treatment of metabolic acidosis by reducing the dietary contribution to overall acid load that must be managed by the kidneys. A recent systematic review and meta-analysis of clinical trials using oral alkali supplements or reduction in dietary acid intake using fruits and vegetables, when compared to no treatment, usual care or placebo found that these treatments increased serum bicarbonate and slowed the decline of kidney function. Fruit and vegetables are an effective and well-tolerated therapy for the treatment of metabolic acidosis in CKD. While oral alkali therapy has known adverse effects, important limitations also exist in the widespread applicability of fruit and vegetables as a treatment for metabolic acidosis. Only 2 single center randomized trials have examined the efficacy of fruit and vegetables for the management for acidosis. This dual-center trial will be the first randomized trial in Canada to evaluate the feasibility of providing fruit and vegetables via home delivery to patients for the management of metabolic acidosis in CKD. This study will be critical in designing a pan-Canadian phase 3 trial testing the efficacy of alkalizing fruit and vegetable provision on slowing the progression of CKD.
- Conditions
- Chronic Kidney Diseases, Metabolic Acidosis
- Being tested
- Alkalizing Fruit and Vegetables, Sodium bicarbonate
- Medical subject headings
- Renal Insufficiency, Chronic, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkalizing Fruit and VegetablesDietary supplement
The weekly deliveries will contain combinations of fresh, frozen, and dried fruits and vegetables, as well as juices and soups which have been selected for their negative potential renal acid load (PRAL) values and shelf-life. All participants will be started at a F+V intake equal to -30 to -40 mEq per day reduction in dietary acid load estimated by the PRAL equation. Participants serum bicarbonate concentration will be measured at 1 month, and at 3 months, those with values < 22 mEq/L will have their recommended amount of F+V increased to -40 to -50 mEq per day. If a participant's 1- or 3-month serum bicarbonate value exceeds 29 mEq/L, their target dose of F+V in mEq/d will be reduced by 25%.
Sodium bicarbonateDrug
Study nephrologist will prescribe the oral alkali therapy (sodium bicarbonate) and the medications will be dispensed by the dispensed by the clinic/hospital pharmacies.
| Study group | Role | What they receive |
|---|---|---|
| Alkalizing Fruit and Vegetables | Experimental | Participants randomized to fruit and vegetables (F+V) will receive weekly supplementation of alkalizing fruits and vegetables via home delivery in a box format. Participants will receive a 1-hour dietary counseling session from a registered dietitian (RD), following randomization, 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 F+V into the participant's current diet. Intervention will last 12 months. Receives: Dietary Supplement: Alkalizing Fruit and Vegetables |
| Sodium Bicarbonate | Active comparator | Participants randomized to the alkali therapy will receive oral sodium bicarbonate 500mg tablets three times a day, reflecting a common starting dose at clinical practice. Thereafter, decisions around dose titration for the sodium bicarbonate will then be transferred to the participant's nephrologist who will be responsible for monitoring the participants serum bicarbonate concentration with a goal of maintaining a serum bicarbonate level >22 mEq/L. Participants will receive counselling from a registered dietician (RD) as part of the standard care. Intervention will last 12 months. Receives: Drug: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomization to preliminary eligible ratio
Ratio of randomized to preliminary eligible greater, calculated among all patients approached to participate expressed as percentage will be collected at 12 months to investigate fruit and vegetable intervention feasibility.
A red, yellow, green framework has been developed as a feasibility metric: green for ratios more than 50%, yellow for ratios 20%-49.9%, and red for ratios less than 20%
Measured: 12 months
Weekly recruitment rate
Number of new participants per weeks of active recruitment. A green, yellow, red feasibility framework has been developed as a feasibility metric: green for ≥ 0.5 , yellow for 0.125-0.49 and red for < 0.125
Measured: 12 months
Study outcome follow up
Study outcome follow up expressed as a percentage, will be calculated at 12 months to investigate the fruit and vegetable intervention feasibility. A red, yellow, green feasibility framework has been developed as a feasibility metric: green for ≥ 95% , yellow for 80%-94.9% and red for <80%.
Measured: 12 months
Potential renal acid load (PRAL) in mEq/day
Calculated from average dietary intake assessed by Automated Self-Administered 24-hour Canada (ASA24) dietary recall survey conducted over three days. a red, yellow, green feasibility framework has been developed as a feasibility metric: green for > 75% , yellow for 50%-75% and red for <50%.
Measured: Baseline, 6, and 12 months
Secondary outcomes (23)
Five repetition chair stand time
the amount of time it takes for a participant to get up out of a chair five times measured in seconds
Measured: Baseline, 3, 6, 9, and 12 months
Physical function related quality of life
Participants will complete the SF-12 physical component score of the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. The questionnaire is scored between 0-100 with higher values representing physical function related quality of life.
Measured: Baseline, 3, 6, 9, and 12 months
Serum bicarbonate (total CO2)
Serum bicarbonate concentration in milliequivalents per liter (mEq/L)
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Albumin
blood albumin is measured in grams per deciliter (g/dL)
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Calcium
Total blood calcium concentration in mmol/L
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Estimated Glomerular Filtration Rate (eGFR)
calculated from serum creatinine, sex, and age, reported in mL/min/1.73 m2
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Glucose
Total blood glucose concentration in mmol/L
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Potassium
The total blood potassium concentration in mmol/L
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Chloride
Total blood chloride concentration in mmol/L
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Sodium
The total sodium concentration in mmol/L
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Phosphorus
The total blood phosphorus concentration in mmol/L
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Hemoglobin A1c
Hemoglobin A1c in percentage
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Blood Urea Nitrogen (BUN)
Blood Urea Nitrogen (BUN) is reported in millimole per litre (mmol/L)
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Urine Albumin/Creatinine Ratio
The ratio of albumin to creatinine concentrations in urine, reported in Milligrams albumin per millimole creatinine
Measured: Baseline, 1, 3, 6, 9, and 12 month(s)
Changes in medication
Research coordinator will update information on concomitant medications or supplements information with the participant
Measured: Baseline,1, 3, 6, 9, and 12 months
Systolic blood pressure in mmHg
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: Baseline, 1, 3, 6, 9, and 12 months
Diastolic blood pressure in mmHg
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: Baseline, 1, 3, 6, 9, and 12 months
Edmonton Symptom Assessment System (ESAS) - Revised Renal
A questionnaire used to rate the intensity of nine common symptoms experienced by renal patients, including pain, tiredness, drowsiness, nausea, appetite levels, shortness of breath, depression and anxiety levels, and well-being. Minimum value 0 and maximum value 100 with higher values being worse.
Measured: Baseline, 3, 6, 9, and 12 months
All cause hospitalization
Information on recent hospitalizations from participant's clinical records will be collected.
Measured: 3, 6, 9, and 12 months
All cause mortality
Information on mortality from participant's clinical records will be collected.
Measured: 3, 6, 9, 12 months
Height
Height will be measured using a validated stadiometer in centimeters..
Measured: Baseline, 3, 6, 9, and 12 months
Weight
Weight will be measured using a calibrated scale in kilograms.
Measured: Baseline, 3, 6, 9, and 12 months
Body Mass Index (BMI)
MBI will be calculated through dividing weight in kilograms (kg) by the square of height in meters (m2).
Measured: Baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start4 Aug 2023
- Primary completion24 Sep 2026
- Study completion24 Sep 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 DiseasesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dylan MacKay
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, Mount Saint Vincent University
- Responsible party
- Sponsor-investigator, Dylan MacKay, University of Manitoba
- Investigators
- Navdeep Tangri, MD, PhD, Principal investigator, Seven Oaks General Hospital Chronic Disease Innovation CentreDylan MacKay, PhD, Principal investigator, George and Fay Yee Centre for Healthcare InnovationKarthik Tennankore, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113641
- Sponsor's protocol ID
- HS24768 (B2021:025)
- Acronym
- ReDACKD
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mollard R, Cachero K, Luhovyy B, Martin H, Moisiuk S, Mahboobi S, Balshaw R, Collister D, Cahill L, Tennankore KK, Tangri N, MacKay D. Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD): A Clinical Research Protocol. Can J Kidney Health Dis. 2023 Aug 7;10:20543581231190180. doi: 10.1177/20543581231190180. eCollection 2023.
PubMed 37560749
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) Feasibility Trial
- ClinicalTrials.gov ID
- NCT05113641
- Acronym / sponsor ID
- ReDACKD / HS24768 (B2021:025)
- Conditions
- Chronic Kidney Diseases, Metabolic Acidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dylan MacKayUniversity, hospital or other
- Collaborators
- Dalhousie University, Mount Saint Vincent University
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 9 Nov 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.
Metabolic acidosis is a common problem that occurs with worsening chronic kidney disease. Dietary acid can build up when the kidneys are not working well. This can be associated with a higher risk of worsening kidney function and death. The usual treatment is a medication called sodium bicarbonate which works to balance the acids in the body. The medication however often does not work and causes side effects. Consumption of alkalizing fruit and vegetables may work as a treatment for metabolic acidosis. This trial is being done to see if fruit and vegetables, provided via home delivery, can become a viable management for metabolic acidosis in patients with chronic kidney disease.
Detailed description
Metabolic acidosis is a common complication of advanced chronic kidney disease (CKD). As kidney function declines, the ability to excrete excess dietary acid is reduced. This can lead to the development of metabolic acidosis, an imbalance in the body's acid-base balance. Metabolic acidosis is associated with a higher risk of CKD progression and mortality. Typical treatment includes an oral alkali, such as sodium citrate or sodium bicarbonate. Recent studies have shown that the treatment of metabolic acidosis can reduce the decline in kidney function and potentially prevent progression of CKD to dialysis. Treatment rates with an oral alkali are low because the treatments are ineffective, often poorly tolerated, and may be associated with net harm. Base producing fruit and vegetables are a potential treatment of metabolic acidosis by reducing the dietary contribution to overall acid load that must be managed by the kidneys. A recent systematic review and meta-analysis of clinical trials using oral alkali supplements or reduction in dietary acid intake using fruits and vegetables, when compared to no treatment, usual care or placebo found that these treatments increased serum bicarbonate and slowed the decline of kidney function. Fruit and vegetables are an effective and well-tolerated therapy for the treatment of metabolic acidosis in CKD. While oral alkali therapy has known adverse effects, important limitations also exist in the widespread applicability of fruit and vegetables as a treatment for metabolic acidosis. Only 2 single center randomized trials have examined the efficacy of fruit and vegetables for the management for acidosis. This dual-center trial will be the first randomized trial in Canada to evaluate the feasibility of providing fruit and vegetables via home delivery to patients for the management of metabolic acidosis in CKD. This study will be critical in designing a pan-Canadian phase 3 trial testing the efficacy of alkalizing fruit and vegetable provision on slowing the progression of CKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alkalizing Fruit and Vegetables | Experimental | Dietary Supplement: Alkalizing Fruit and VegetablesParticipants randomized to fruit and vegetables (F+V) will receive weekly supplementation of alkalizing fruits and vegetables via home delivery in a box format. Participants will receive a 1-hour dietary counseling session from a registered dietitian (RD), following randomization, 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 F+V into the participant's current diet. Intervention will last 12 months. |
| Sodium Bicarbonate | Active comparator | Drug: Sodium bicarbonateParticipants randomized to the alkali therapy will receive oral sodium bicarbonate 500mg tablets three times a day, reflecting a common starting dose at clinical practice. Thereafter, decisions around dose titration for the sodium bicarbonate will then be transferred to the participant's nephrologist who will be responsible for monitoring the participants serum bicarbonate concentration with a goal of maintaining a serum bicarbonate level >22 mEq/L. Participants will receive counselling from a registered dietician (RD) as part of the standard care. Intervention will last 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or Female, aged 18 years or above
- Participants who have an eGFR between 15 and 40 ml/min/1.73m2
- Two consecutive measurements of serum bicarbonate of 14 to 22 mEq/L
- Systolic and diastolic blood pressure <160/100 mmHg
Key exclusion criteria (8 listed)
- Anuria, dialysis or acute kidney injury/acute kidney failure in the 3 months prior to screening
- Chronic obstructive pulmonary disease that requires the participant to be on oxygen
- New York Heart Association Class 3-4 Heart failure 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 GI 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 |
|---|---|---|
| Alkalizing Fruit and VegetablesThe weekly deliveries will contain combinations of fresh, frozen, and dried fruits and vegetables, as well as juices and soups which have been selected for their negative potential renal acid load (PRAL) values and shelf-life. All participants will be started at a F+V intake equal to -30 to -40 mEq per day reduction in dietary acid load estimated by the PRAL equation. Participants serum bicarbonate concentration will be measured at 1 month, and at 3 months, those with values < 22 mEq/L will have their recommended amount of F+V increased to -40 to -50 mEq per day. If a participant's 1- or 3-month serum bicarbonate value exceeds 29 mEq/L, their target dose of F+V in mEq/d will be reduced by 25%. | Dietary supplement | Alkalizing Fruit and Vegetables |
| Sodium bicarbonateStudy nephrologist will prescribe the oral alkali therapy (sodium bicarbonate) and the medications will be dispensed by the dispensed by the clinic/hospital pharmacies. | Drug | Sodium Bicarbonate |
Primary outcome
Randomization to preliminary eligible ratio
Time frame: 12 months
Ratio of randomized to preliminary eligible greater, calculated among all patients approached to participate expressed as percentage will be collected at 12 months to investigate fruit and vegetable intervention feasibility. A red, yellow, green framework has been developed as a feasibility metric: green for ratios more than 50%, yellow for ratios 20%-49.9%, and red for ratios less than 20%
Weekly recruitment rate
Time frame: 12 months
Number of new participants per weeks of active recruitment. A green, yellow, red feasibility framework has been developed as a feasibility metric: green for ≥ 0.5 , yellow for 0.125-0.49 and red for < 0.125
Study outcome follow up
Time frame: 12 months
Study outcome follow up expressed as a percentage, will be calculated at 12 months to investigate the fruit and vegetable intervention feasibility. A red, yellow, green feasibility framework has been developed as a feasibility metric: green for ≥ 95% , yellow for 80%-94.9% and red for <80%.
Potential renal acid load (PRAL) in mEq/day
Time frame: Baseline, 6, and 12 months
Calculated from average dietary intake assessed by Automated Self-Administered 24-hour Canada (ASA24) dietary recall survey conducted over three days. a red, yellow, green feasibility framework has been developed as a feasibility metric: green for > 75% , yellow for 50%-75% and red for <50%.
23 secondary outcomes
Five repetition chair stand time
Time frame: Baseline, 3, 6, 9, and 12 months
Physical function related quality of life
Time frame: Baseline, 3, 6, 9, and 12 months
Serum bicarbonate (total CO2)
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Albumin
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Calcium
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Glucose
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Potassium
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Chloride
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Sodium
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Phosphorus
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Hemoglobin A1c
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Blood Urea Nitrogen (BUN)
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Urine Albumin/Creatinine Ratio
Time frame: Baseline, 1, 3, 6, 9, and 12 month(s)
Changes in medication
Time frame: Baseline,1, 3, 6, 9, and 12 months
Systolic blood pressure in mmHg
Time frame: Baseline, 1, 3, 6, 9, and 12 months
Diastolic blood pressure in mmHg
Time frame: Baseline, 1, 3, 6, 9, and 12 months
Edmonton Symptom Assessment System (ESAS) - Revised Renal
Time frame: Baseline, 3, 6, 9, and 12 months
All cause hospitalization
Time frame: 3, 6, 9, and 12 months
All cause mortality
Time frame: 3, 6, 9, 12 months
Height
Time frame: Baseline, 3, 6, 9, and 12 months
Weight
Time frame: Baseline, 3, 6, 9, and 12 months
Body Mass Index (BMI)
Time frame: Baseline, 3, 6, 9, and 12 months
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 23 Oct 2026.
- Derived from this study: PubMed 37560749Mollard R, Cachero K, Luhovyy B, Martin H, Moisiuk S, Mahboobi S, Balshaw R, Collister D, Cahill L, Tennankore KK, Tangri N, MacKay D. Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD): A Clinical Research Protocol. Can J Kidney Health Dis. 2023 Aug 7;10:20543581231190180. doi: 10.1177/20543581231190180. eCollection 2023.
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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.
Navdeep Tangri, MD, PhD principal investigator
Seven Oaks General Hospital Chronic Disease Innovation Centre
Dylan MacKay, PhD principal investigator
George and Fay Yee Centre for Healthcare Innovation
Karthik Tennankore, MD principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alkalizing Fruit and Vegetables and Sodium bicarbonate in people with Chronic Kidney Diseases and Metabolic Acidosis, run by Dylan MacKay 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 9 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 23 Oct 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?
Randomization to preliminary eligible ratio (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT05113641, 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 23 Oct 2026.