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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 fruits and vegetables may work as a treatment for metabolic acidosis. This trial is being done to see if fruits and vegetables, provided via home delivery, can become a viable treatment for metabolic acidosis in patients with chronic kidney disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Dalhousie University; Mount Saint Vincent University

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