Using fruits and vegetables to manage acid levels in chronic kidney disease
Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) Feasibility Trial
This study is testing if eating more fruits and vegetables can help people with chronic kidney disease manage their acid levels better than traditional medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 2 sites (Winnipeg, Manitoba and 1 other locations) |
| Trial ID | NCT05113641 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of consuming alkalizing fruits and vegetables delivered to patients' homes as a treatment for metabolic acidosis in individuals with chronic kidney disease (CKD). It aims to compare this dietary approach with the traditional oral alkali treatment, such as sodium bicarbonate, which often has limited effectiveness and side effects. Participants will be monitored for changes in serum bicarbonate levels and kidney function over the course of the trial. The study is designed to provide a more tolerable and potentially effective alternative for managing metabolic acidosis in CKD patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic kidney disease and specific serum bicarbonate levels.
Not a fit: Patients currently on dialysis or with acute kidney injury are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective dietary management option for patients with chronic kidney disease and metabolic acidosis.
How similar studies have performed: Previous studies have shown that dietary interventions with fruits and vegetables can improve serum bicarbonate levels and slow kidney function decline, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winnipeg, Manitoba and 1 other locations
- Seven Oaks General Hospital Chronic Disease Innovation Centre — Winnipeg, Manitoba, Canada (Recruiting)
- Chronic Kidney Disease (Renal) ClinicQEII - Dickson Building — Halifax, Nova Scotia, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Navdeep Tangri, MD, PhD — Seven Oaks General Hospital Chronic Disease Innovation Centre
- Study coordinator: Rebecca Mollard, PhD
- Email: rmollard@sogh.mb.ca
- Phone: 204-631-3834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.