RecruitingNot ApplicableNCT05113641

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

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


Sponsor

Dylan MacKay

Enrollment

40 participants

Start Date

Aug 4, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (ReDACKD) is comparing two ways to reduce acid load in the body in people with chronic kidney disease (CKD): changing to a more plant-based, low-acid diet versus taking oral baking soda-like supplements (alkali pills). When the kidneys are weakened, they struggle to remove acid from the blood, which speeds up kidney decline. This study explores whether food changes or supplements work better. **You may be eligible if...** - You are 18 or older with a kidney filtration rate (eGFR) between 15 and 40 (moderate to severe CKD) - You have two recent blood tests showing low bicarbonate (a sign of acid buildup) - Your blood pressure is controlled below 160/100 mmHg - Your potassium level is below 5.3 - You are a patient at a nephrology clinic in Winnipeg or Halifax - You can communicate in English **You may NOT be eligible if...** - You are on dialysis or had acute kidney injury in the past 3 months - You have severe COPD requiring oxygen, class 3–4 heart failure, or had a heart attack or stroke in the past 6 months - You are currently on potassium-binding therapy - You are pregnant or breastfeeding - You have participated in another drug trial in the past 12 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTAlkalizing 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%.

DRUGSodium 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.


Locations(3)

Chronic Kidney Disease (Renal) ClinicQEII - Dickson Building

Halifax, Nova Scotia, Canada

Seven Oaks General Hospital Chronic Disease Innovation Centre

Winnipeg, Manitoba, Canada

Health Sciences Center

Winnipeg, Manitoba, Canada

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NCT05113641


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