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
Dylan MacKay
40 participants
Aug 4, 2023
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
Inclusion Criteria9
- 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 Criteria8
- 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
Interventions
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%.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05113641