Clinical trial NCT05113641: Reducing Dietary Acid With Food Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD)
Official title: Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Metabolic Acidosis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: Mount Saint Vincent University
First posted: 2021-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Eligibility to randomization ratio
timeFrame: 12 months
measure: Weekly recruitment rate
timeFrame: 12 months
measure: Study outcome follow up
timeFrame: 12 months
measure: Potential renal acid load (PRAL) in mEq/day
timeFrame: Baseline, 6, and 12 months
Secondary outcomes:
measure: Five repetition chair stand time
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Physical function related quality of life
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Serum bicarbonate (total CO2)
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Albumin
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Calcium
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Glucose
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Potassium
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Chloride
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Sodium
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Phosphorus
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Hemoglobin A1c
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Blood Urea Nitrogen (BUN)
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Urine Albumin/Creatinine Ratio
timeFrame: Baseline, 1, 3, 6, 9, and 12 month(s)
measure: Changes in medication
timeFrame: Baseline,1, 3, 6, 9, and 12 months
measure: Systolic blood pressure in mmHg
timeFrame: Baseline, 1, 3, 6, 9, and 12 months
measure: Diastolic blood pressure in mmHg
timeFrame: Baseline, 1, 3, 6, 9, and 12 months
measure: Edmonton Symptom Assessment System (ESAS) - Revised Renal
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: All cause hospitalization
timeFrame: 3, 6, 9, and 12 months
measure: All cause mortality
timeFrame: 3, 6, 9, 12 months
measure: Height
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Weight
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Body Mass Index (BMI)
timeFrame: Baseline, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Seven Oaks General Hospital Chronic Disease Innovation Centre
state: Manitoba
city: Halifax
country: Canada
facility: Chronic Kidney Disease (Renal) ClinicQEII - Dickson Building
state: Nova Scotia
Study officials:
affiliation: Seven Oaks General Hospital Chronic Disease Innovation Centre
name: Navdeep Tangri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: George and Fay Yee Centre for Healthcare Innovation
name: Dylan MacKay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Karthik Tennankore, MD
role: PRINCIPAL_INVESTIGATOR
References: