Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD: A Randomized Phase 2 Pilot Trial
Open accessAbstract
Background and objectives Endothelial dysfunction is common among patients with CKD. We tested the efficacy and safety of combination treatment with sodium nitrite and isoquercetin on biomarkers of endothelial dysfunction in patients with CKD. Design, setting, participants, & measurements This randomized, double-blind, placebo-controlled phase 2 pilot trial enrolled 70 patients with predialysis CKD. Thirty-five were randomly assigned to combination treatment with sodium nitrite (40 mg twice daily) and isoquercetin (225 mg once daily) for 12 weeks, and 35 were randomly assigned to placebo. The primary outcome was mean change in flow-mediated vasodilation over the 12-week intervention. Secondary and safety outcomes included biomarkers of endothelial dysfunction, inflammation, and oxidative stress as well as kidney function, methemoglobin, and adverse events. Intention-to-treat analysis was conducted. Results Baseline characteristics, including age, sex, race, cigarette smoking, history of hypertension and diabetes, use of renin-angiotensin system blockers, BP, fasting glucose, lipid profile, kidney function, urine albumin-creatinine ratio, and endothelial biomarkers, were comparable between groups. Over the 12-week intervention, flow-mediated vasodilation increased 1.1% (95% confidence interval, −0.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, −0.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, −0.9 to 2.5). In addition, changes in biomarkers of endothelial dysfunction (vascular adhesion molecule-1, intercellular adhesion molecule-1, E-selectin, vWf, endostatin, and asymmetric dimethylarginine), inflammation (TNF- α , IL-6, C-reactive protein, IL-1 receptor antagonist, and monocyte chemoattractant protein-1), and oxidative stress (oxidized LDL and nitrotyrosines) were not significantly different between the two groups. Furthermore, changes in eGFR, urine albumin-creatinine ratio, methemoglobin, and adverse events were not significantly different between groups. Conclusions This randomized phase 2 pilot trial suggests that combination treatment with sodium nitrite and isoquercetin did not significantly improve flow-mediated vasodilation or other endothelial function biomarkers but also did not increase adverse events compared with placebo among patients with CKD. Clinical Trial registry name and registration number: Nitrite, Isoquercetin, and Endothelial Dysfunction (NICE), NCT02552888
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Small-scale studies have reported reductions in blood pressure and renal resistance index following nitrate intake in CKD.
“small-scale studies have reported reductions in blood pressure and renal resistance index following nitrate intake.”
From Dietary Nitrate-Rich Vegetables as Natural Modulators of Health: Mechanisms and Benefits in Ageing Populations (2026) · cites this paper as [221]
The effects of nitrate intake on renal function markers (eGFR and albuminuria) in CKD remain inconclusive.
“the effects on renal function markers (e.g., eGFR and albuminuria) remain inconclusive [220,221].”
From Dietary Nitrate-Rich Vegetables as Natural Modulators of Health: Mechanisms and Benefits in Ageing Populations (2026) · cites this paper as [221]
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- Authors
- Chen, J., Hamm, L. L., Bundy, J. D., Kumbala, D. R., Bodana, S., Chandra, S., Chen, C.-S., Starcke, C. C., Guo, Y., Schaefer, C. M., Lustigova, E., Mahone, E., Vadalia, A. M., Livingston, T., Obst, K., Hernandez, J., Bokhari, S. R., Kleinpeter, M., Alper, A. B., Lukitsch, I., He, H., Nieman, D. C., & He, J.
- Affiliations
- Tulane University (US)
- Renal Associates of Baton Rouge, Baton Rouge, Louisiana
- Ochsner Health System (US)
- University of Pennsylvania (US)
- Appalachian State University (US)
- ORCID
- Venue
- Clinical Journal of the American Society of Nephrology
- Published
- 2020-10-06
- Volume
- 15
- Issue
- 11
- Pages
- 1566-1575
- ISSN
- 1555-9041 (ISSN-L)
- 1555-905X
- PMC
- PMC7646238
- OpenAlex
- W3091949616
- Cited by
- 16
- References
- 47
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 2 · 2023: 2 · 2022: 4
- FWCI
- 0.90
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Clinical Journal of the American Society of Nephrology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of General Medical Sciences of the National Institutes of Health (U54 GM104940)
- National Institute of Health (NIH); National Institute of General Medical Sciences (P20 GM109036)
- NIH; NIGMS (P30-GM103337)
- Topics
- Health Sciences › Medicine › Physiology › Nitric Oxide and Endothelin Effects
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Keywords
- sodium nitrite, isoquercitrin, endothelial dysfunction, chronic kidney disease, flow-mediated dilation, pre-dialysis CKD, oxidative stress, inflammation, methemoglobin, asymmetric dimethylarginine, endostatin, nitric oxide donors, flavonoids, combination therapy, endothelial markers, oxidative stress biomarkers, inflammatory markers, EGFR
- MeSH terms
- Aged, Antioxidants, Arginine, Drug Therapy, Combination, Endothelium, Female, Glomerular Filtration Rate, Amine Oxidase (Copper-Containing), Humans, Inflammation, Male, Middle Aged, Pilot Projects, Quercetin, Sodium Nitrite, Vasodilation, von Willebrand Factor, Biomarkers, Cell Adhesion Molecules, Oxidative Stress, Intercellular Adhesion Molecule-1, E-Selectin, Endostatins, Renal Insufficiency, Chronic, Medication Adherence
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