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| Name | Class |
|---|---|
| Dalhousie University | OTHER |
| Mount Saint Vincent University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alkalizing Fruit and Vegetables | Dietary 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 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 | 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%. | 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%. | Baseline, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3, 6, 9, and 12 months |
| Physical function related quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Exit Interviews | Upon the completion of the 12 months of study, the participants will be invited to participate in an exit interview. This interview will involve a few open ended question and its goal is to better understand participants' personal experiences and perspectives of the study and the intervention they received, as well as their overall viewpoints of trials such as ReDACKD, as a person living with CKD and metabolic acidosis. We will offer the interview to all of the participants at the final visit of the trial; however, taking part is this interview is voluntary. The "Exit Interview Consent Form" will be used to explain the aims and procedures of the interview |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Navdeep Tangri, MD, PhD | Seven Oaks General Hospital Chronic Disease Innovation Centre | Principal Investigator |
| Dylan MacKay, PhD | George and Fay Yee Centre for Healthcare Innovation | Principal Investigator |
| Karthik Tennankore, MD | Nova Scotia Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seven Oaks General Hospital Chronic Disease Innovation Centre | Winnipeg | Manitoba | R2V 3M3 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37560749 | Derived | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014675 | Vegetables |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Sodium bicarbonate | Drug | Study nephrologist will prescribe the oral alkali therapy (sodium bicarbonate) and the medications will be dispensed by the dispensed by the clinic/hospital pharmacies. |
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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.
| Baseline, 3, 6, 9, and 12 months |
| Serum bicarbonate (total CO2) | Serum bicarbonate concentration in milliequivalents per liter (mEq/L) | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Albumin | blood albumin is measured in grams per deciliter (g/dL) | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Calcium | Total blood calcium concentration in mmol/L | 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 | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Glucose | Total blood glucose concentration in mmol/L | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Potassium | The total blood potassium concentration in mmol/L | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Chloride | Total blood chloride concentration in mmol/L | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Sodium | The total sodium concentration in mmol/L | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Phosphorus | The total blood phosphorus concentration in mmol/L | Baseline, 1, 3, 6, 9, and 12 month(s) |
| Hemoglobin A1c | Hemoglobin A1c in percentage | 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) | 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 | 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 | 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. | 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. | 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. | Baseline, 3, 6, 9, and 12 months |
| All cause hospitalization | Information on recent hospitalizations from participant's clinical records will be collected. | 3, 6, 9, and 12 months |
| All cause mortality | Information on mortality from participant's clinical records will be collected. | 3, 6, 9, 12 months |
| Height | Height will be measured using a validated stadiometer in centimeters.. | Baseline, 3, 6, 9, and 12 months |
| Weight | Weight will be measured using a calibrated scale in kilograms. | 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). | Baseline, 3, 6, 9, and 12 months |
| Final Visit (Month 12)-After the completion of the trial |
| Chronic Kidney Disease (Renal) ClinicQEII - Dickson Building |
| Halifax |
| Nova Scotia |
| B3H 2Y9 |
| Canada |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001639 |
| Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |