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

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

Interventions

DIETARY_SUPPLEMENT

Alkalizing Fruit and Vegetables

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%.

DRUG

Sodium bicarbonate

Study nephrologist will prescribe the oral alkali therapy (sodium bicarbonate) and the medications will be dispensed by the dispensed by the clinic/hospital pharmacies.

Sponsors & Collaborators

• Dalhousie University

  collaborator OTHER

• Mount Saint Vincent University

  collaborator OTHER

• Dylan MacKay

  lead OTHER

Principal Investigators

• Navdeep Tangri, MD, PhD · Seven Oaks General Hospital Chronic Disease Innovation Centre

• Dylan MacKay, PhD · George and Fay Yee Centre for Healthcare Innovation

• Karthik Tennankore, MD · Nova Scotia Health Authority

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-04

Primary Completion

2026-07-31

Completion

2026-09-30

Countries

• Canada

Study Locations