What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include the use of sodium bicarbonate and sodium-potassium citrate as oral alkalinizing agents to manage metabolic acidosis. These treatments can cause side effects such as gastrointestinal discomfort, bloating, and in some cases, electrolyte imbalances like hyperkalemia. Additionally, while sodium bicarbonate is effective in balancing body acids, it may not always work and can lead to side effects such as increased sodium levels, which can exacerbate hypertension and fluid retention. The trial involving alkalizing fruits and vegetables aims to provide a dietary alternative that may reduce these side effects while managing metabolic acidosis.

What prior FDA approvals exist?

The FDA has approved sodium bicarbonate as a standard treatment for managing metabolic acidosis in patients with chronic kidney disease. This medication helps to neutralize excess acid in the body, which is a common issue as kidney function declines. While there are ongoing studies exploring the use of alkalizing fruits and vegetables as a dietary intervention to achieve similar outcomes, sodium bicarbonate remains the primary FDA-approved treatment for this aspect of CKD management.

What other types of research exist?

Promising novel alternatives to alkalizing fruits and vegetables for CKD patients include the use of oral sodium bicarbonate protocols and other alkalinizing agents like potassium citrate. Additionally, ongoing research into dietary modifications and the use of novel pharmacological agents that target acid-base balance may offer new treatment options in 2024.

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Dietary Supplement

Diet Modification for Chronic Kidney Disease (ReDACKD Trial)

N/A

Recruiting

Led By Karthik Tennankore, MD

Research Sponsored by Dylan MacKay

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who have an eGFR between 15 and 40 ml/min/1.73m2

Be older than 18 years old

Must not have

Currently on potassium binding therapy

Unable to consume study treatments or control, such as swallowing or GI issues

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,1, 3, 6, 9, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if home-delivered fruits and vegetables can help manage metabolic acidosis in patients with chronic kidney disease. These patients often do not respond well to usual care. The fruits and vegetables help by reducing the acid levels in the body, which may slow down kidney damage. Recent studies have shown that base-producing fruits and vegetables might yield better health outcomes for CKD patients compared to usual care.

Who is the study for?

The ReDACKD trial is for adults with chronic kidney disease who are not pregnant, haven't had a recent heart attack or stroke, and don't have severe heart failure or lung disease requiring oxygen. They should be able to eat fruits and vegetables without difficulty, have certain levels of blood markers within specific ranges, and not be on dialysis.

What is being tested?

This study tests if eating alkalizing fruits and vegetables can manage metabolic acidosis better than the usual treatment with sodium bicarbonate pills in people with chronic kidney disease. Participants will receive these foods delivered to their homes to see if this approach improves their condition.

What are the potential side effects?

While the trial's main focus is on dietary changes rather than medication, potential side effects may include discomfort from increased fruit and vegetable intake such as bloating or gas. Sodium bicarbonate can cause stomach upset, nausea, or swelling due to fluid retention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by eGFR, is between 15 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication to manage my potassium levels.

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I cannot swallow pills or have digestive issues that prevent me from taking certain medications.

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I am currently pregnant or breastfeeding.

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I have severe heart failure symptoms or have had a heart, liver, or kidney transplant.

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I have COPD and need oxygen therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,1, 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,1, 3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,1, 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Eligibility to randomization ratio

Potential renal acid load (PRAL) in mEq/day

Study outcome follow up

+1 more

Secondary study objectives

Albumin

All cause hospitalization

All cause mortality

+20 more

Other study objectives

All cause hospitalization and all cause mortality

Treatment discontinuation rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Alkalizing Fruit and VegetablesExperimental Treatment1 Intervention

Participants randomized to fruit and vegetables (F+V) will receive weekly supplementation of alkalizing fruits and vegetables via home delivery in a box format. Participants will receive a 1-hour dietary counseling session in the first week from a registered dietitian (RD), either in person or via videoconference, depending on regional coronavirus disease (COVID) 19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the F+V into the participant's current diet. Intervention will last 12 months.

Group II: Sodium BicarbonateActive Control1 Intervention

Participants randomized to the alkali therapy will receive oral sodium bicarbonate 500mg tablets three times a day, reflecting a common starting dose at clinical practice. Thereafter, decisions around dose titration for the sodium bicarbonate will then be transferred to the participant's nephrologist who will be responsible for monitoring the participants serum bicarbonate concentration with a goal of maintaining a serum bicarbonate level \>22 mEq/L. Participants will receive counselling from a registered dietician (RD) as part of the standard care. Intervention will last 12 months.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) include the use of medications like ACE inhibitors and ARBs to control blood pressure and reduce proteinuria, as well as dietary modifications to manage metabolic acidosis. Alkalizing agents, such as sodium bicarbonate or sodium-potassium citrate, work by neutralizing excess dietary acid, which can help prevent further kidney damage and slow disease progression. Similarly, the consumption of alkalizing fruits and vegetables can reduce dietary acid load, potentially improving kidney function and overall health. This approach is particularly important for CKD patients as it helps maintain acid-base balance, reduces the risk of metabolic acidosis, and may improve long-term outcomes.

Reno-protective effects of oral alkalizing agents in chronic kidney disease with aciduria: protocol for a randomized cohort study.Effect of Treatment of Metabolic Acidosis on Vascular Endothelial Function in Patients with CKD: A Pilot Randomized Cross-Over Study.