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Dietary Supplement

Beetroot Juice Therapy for Chronic Kidney Disease

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
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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:
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I haven't donated blood in the last 8 weeks and won't donate for 8 weeks after the study.
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I have been treated for vasculitis with immune-suppressing drugs in the past year.
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I am taking Warfarin.
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I have a history of severe heart failure.
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I am currently fighting an infection or taking antibiotics.
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I have a history of severe liver disease.
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I have a G6PD deficiency or high methemoglobin levels.

Timeline

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.

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.

Find a Location

Who is running the clinical trial?

University of Colorado, BoulderLead Sponsor
124 Previous Clinical Trials
29,430 Total Patients Enrolled
Matthew J Rossman, PhDPrincipal InvestigatorUniversity of Colorado, Boulder
3 Previous Clinical Trials
174 Total Patients Enrolled

Media Library

Nitrate-rich beetroot juice (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03826147 — Phase 4
Chronic Kidney Disease Research Study Groups: Nitrate-rich beetroot juice, Nitrate-depleted beetroot juice
Chronic Kidney Disease Clinical Trial 2023: Nitrate-rich beetroot juice Highlights & Side Effects. Trial Name: NCT03826147 — Phase 4
Nitrate-rich beetroot juice (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03826147 — Phase 4
~14 spots leftby Dec 2025