Reducing Dietary Acid With Food Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD)

NCT05113641 | Active Not Recruiting DMC

• 1 other identifier: HS24768 (B2021:025)
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Diseases; Metabolic Acidosis

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (23)

• Five repetition chair stand time

  Baseline, 3, 6, 9, and 12 months

• Physical function related quality of life

  Baseline, 3, 6, 9, and 12 months

• Serum bicarbonate (total CO2)

  Baseline, 1, 3, 6, 9, and 12 month(s)

• Albumin

  Baseline, 1, 3, 6, 9, and 12 month(s)

• Calcium

  Baseline, 1, 3, 6, 9, and 12 month(s)

Other Outcomes (1)

• Exit Interviews

  Final Visit (Month 12)-After the completion of the trial

Study Arms (2)

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.

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.

Drug: Sodium bicarbonate

Interventions

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%.

Alkalizing Fruit and Vegetables

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.

Sodium Bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dylan MacKay: lead
• Dalhousie University: collaborator
• Mount Saint Vincent University: collaborator

Study Sites (2)

Seven Oaks General Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, R2V 3M3, Canada

Location

Chronic Kidney Disease (Renal) ClinicQEII - Dickson Building

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

• 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.

  PMID: 37560749 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acidosis

Interventions

Vegetables; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 9, 2021
• Study Start: August 4, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CA (2)