Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) Feasibility Trial

Who is this study for? Patients with Chronic Kidney Diseases, Metabolic Acidosis
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Chronic Kidney Disease (Renal) ClinicQEII - Dickson Building
ACTIVE_NOT_RECRUITING
Halifax
Health Sciences Center
RECRUITING
Winnipeg
Seven Oaks General Hospital Chronic Disease Innovation Centre
RECRUITING
Winnipeg
Contact Information
Primary
Rebecca Mollard, PhD
rmollard@sogh.mb.ca
204-631-3834
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2026-09
Participants
Target number of participants: 40
Treatments
Experimental: Alkalizing Fruit and Vegetables
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.
Active_comparator: Sodium Bicarbonate
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.
Authors
Leah Cahill, Karthik Tennankore
Related Therapeutic Areas
Sponsors
Collaborators: Dalhousie University, Mount Saint Vincent University
Leads: Dylan MacKay

This content was sourced from clinicaltrials.gov