What is the mechanism of action of this treatment?

Common treatments for Chronic Kidney Disease (CKD) include medications like ACE inhibitors and ARBs, which help control blood pressure and reduce proteinuria, and lifestyle interventions such as dietary modifications. Nitrate-rich beetroot juice, which increases nitric oxide (NO) levels, is being studied for its potential benefits in CKD. NO is crucial for vascular health as it helps dilate blood vessels, improving blood flow and reducing blood pressure. This is particularly important for CKD patients, as improved vascular function can slow the progression of kidney damage and reduce the risk of cardiovascular complications, which are common in CKD.

What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) that aim to increase nitric oxide (NO) levels, such as nitrate-rich beetroot juice, generally have mild side effects. These can include gastrointestinal discomfort, such as bloating, gas, and diarrhea. Other treatments for CKD, like antihypertensive medications (e.g., ACE inhibitors, ARBs), may cause side effects such as dizziness, increased potassium levels, and kidney function changes. It's important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What other types of research exist?

Promising alternatives to nitrate-rich beetroot juice for CKD patients include L-arginine and L-citrulline supplements, which are precursors to nitric oxide and have been shown to improve vascular function. Additionally, antioxidants like vitamin C and E may support nitric oxide production and improve endothelial function. These alternatives should be discussed with a healthcare provider to ensure safety and efficacy.

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Dietary Supplement

Beetroot Juice Therapy for Chronic Kidney Disease

Q: What prior FDA approvals exist?

FDA-approved treatments for Chronic Kidney Disease (CKD) primarily focus on managing symptoms and slowing disease progression. While specific drugs that increase nitric oxide (NO) levels like nitrate-rich beetroot juice are not commonly highlighted, other treatments include antihypertensive agents such as ACE inhibitors and ARBs, which help control blood pressure and reduce proteinuria. Additionally, medications like sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown benefits in CKD patients by improving kidney function and cardiovascular outcomes. These treatments aim to address the underlying causes and complications of CKD, rather than directly increasing NO levels.

Phase 4

Recruiting

Led By Matthew J Rossman, PhD

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

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

Must have

CKD stage II-IV (eGFR using the Modification of Diet in Renal Disease (MDRD) prediction equation 20-90 mL/min/1.73m2; stable renal function in the past 3 months)

Be older than 18 years old

Must not have

Blood donation within 8 weeks prior to enrolling in the study; unwilling to abstain from donating blood for 8 weeks after completing the study

Vasculitis requiring immunosuppressive therapy within the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if drinking beetroot juice daily can help people with chronic kidney disease by improving their blood flow, movement, and thinking abilities. The juice works by boosting a molecule called nitric oxide in the body. Beetroot is known for its high concentration of inorganic nitrate, which can be converted into nitric oxide, potentially benefiting patients with chronic kidney disease by reducing blood pressure and improving renal function.

Who is the study for?

This trial is for people with chronic kidney disease stages II-IV who can perform basic motor and cognitive tests, have a stable body weight (BMI <40), normal albumin levels, and blood pressure above 100/60 mmHg. They shouldn't be hospitalized recently, on warfarin, or have severe heart/liver conditions.

What is being tested?

The study tests if drinking nitrate-rich beetroot juice daily for three months improves blood vessel health, movement ability, and brain function in CKD patients by boosting nitric oxide levels compared to a nitrate-depleted version.

What are the potential side effects?

Potential side effects may include low blood pressure due to the vasodilating effect of nitrates. There's also a small risk of changes in the oxygen-carrying capacity of the blood (methemoglobinemia) especially in those with G6PD deficiency.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidney function is moderately to severely reduced but stable.

Exclusion Criteria

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

Select...

I haven't donated blood in the last 8 weeks and won't donate for 8 weeks after the study.

Select...

I have been treated for vasculitis with immune-suppressing drugs in the past year.

Select...

I am taking Warfarin.

Select...

I have a history of severe heart failure.

Select...

I am currently fighting an infection or taking antibiotics.

Select...

I have a history of severe liver disease.

Select...

I have a G6PD deficiency or high methemoglobin levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 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

Change in aortic stiffness

Change in vascular endothelial function

Secondary study objectives

Change in endothelial cell markers of oxidative stress

Change in oxidative stress-associated suppression of endothelial function assessed as the increase in brachial artery flow-mediated dilation following an ascorbic acid infusion

Other study objectives

Fluid cognition composite score

Motor function composite score

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Nitrate-rich beetroot juiceActive Control1 Intervention

Daily dose of nitrate-rich beetroot juice (70 mL) for 3 months.

Group II: Nitrate-depleted beetroot juicePlacebo Group1 Intervention

Daily dose of nitrate-depleted beetroot juice (70 mL) for 3 months. The nitrate-depleted beetroot juice is identical in appearance, taste and caloric content to nitrate-rich beetroot juice, but with nitrate removed.

0 / 8Eligibility 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 medications like ACE inhibitors and ARBs, which help control blood pressure and reduce proteinuria, and lifestyle interventions such as dietary modifications. Nitrate-rich beetroot juice, which increases nitric oxide (NO) levels, is being studied for its potential benefits in CKD. NO is crucial for vascular health as it helps dilate blood vessels, improving blood flow and reducing blood pressure. This is particularly important for CKD patients, as improved vascular function can slow the progression of kidney damage and reduce the risk of cardiovascular complications, which are common in CKD.

Promoting Plant-Based Therapies for Chronic Kidney Disease.Nephroprotective effects of red beetroot-based beverages against gentamicin-induced renal stress.Effects of folic acid on renal endothelial function in patients with diabetic nephropathy: results from a randomized trial.