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Clinical Trial 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.

Clinical Trial Description

Metabolic acidosis is a common complication of advanced chronic kidney disease (CKD). As kidney function declines, the ability to excrete excess dietary acid is reduced. This can lead to the development of metabolic acidosis, an imbalance in the body's acid-base balance. Metabolic acidosis is associated with a higher risk of CKD progression and mortality. Typical treatment includes an oral alkali, such as sodium citrate or sodium bicarbonate. Recent studies have shown that the treatment of metabolic acidosis can reduce the decline in kidney function and potentially prevent progression of CKD to dialysis. Treatment rates with an oral alkali are low because the treatments are ineffective, often poorly tolerated, and may be associated with net harm. Base producing fruit and vegetables are a potential treatment of metabolic acidosis by reducing the dietary contribution to overall acid load that must be managed by the kidneys. A recent systematic review and meta-analysis of clinical trials using oral alkali supplements or reduction in dietary acid intake using fruits and vegetables, when compared to no treatment, usual care or placebo found that these treatments increased serum bicarbonate and slowed the decline of kidney function. Fruits and vegetables are an effective and well-tolerated therapy for the treatment of metabolic acidosis in CKD. While oral alkali therapy has known adverse effects, important limitations also exist in the widespread applicability of fruits and vegetables as a treatment for metabolic acidosis. Only 2 single center randomized trials have examined the efficacy of fruits and vegetables as a treatment for acidosis. This dual-center pilot trial will be the first randomized trial in Canada to evaluate the feasibility of providing fruits and vegetables via home delivery to patients as a treatment for CKD and metabolic acidosis. This study will be critical in designing a pan-Canadian phase 3 trial testing the efficacy of alkalizing fruits and vegetable provision on slowing the progression of CKD. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05113641
Study type Interventional
Source University of Manitoba
Contact Rebecca Mollard, PhD
Phone 204-631-3834
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date November 2021
Completion date April 2024

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