{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T21:11:48Z","timestamp":1792098708257,"version":"4.4.0"},"reference-count":43,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","funder":[{"name":"National Institute of General Medical Sciences of the National Institutes of Health","award":["U54 GM104940"],"award-info":[{"award-number":["U54 GM104940"]}]},{"name":"National Institute of Health (NIH); National Institute of General Medical Sciences","award":["P20 GM109036"],"award-info":[{"award-number":["P20 GM109036"]}]},{"name":"NIH; NIGMS","award":["P30-GM103337"],"award-info":[{"award-number":["P30-GM103337"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["CJASN"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background and objectives<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design, setting, participants, &amp; measurements<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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, \u22120.1 to 2.3) in the treatment group and 0.3% (95% confidence interval, \u22120.9 to 1.5) in the placebo group, and net change was 0.8% (95% confidence interval, \u22120.9 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-\n                      <jats:italic toggle=\"yes\">\u03b1<\/jats:italic>\n                      , 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial registry name and registration number:<\/jats:title>\n                    <jats:p>Nitrite, Isoquercetin, and Endothelial Dysfunction (NICE), NCT02552888<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2215\/cjn.02020220","type":"journal-article","created":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T18:05:18Z","timestamp":1602007518000},"page":"1566-1575","source":"Crossref","is-referenced-by-count":18,"title":["Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD"],"prefix":"10.2215","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct02552888","registry":"10.18810\/clinical-trials-gov","type":"results"},{"clinical-trial-number":"nct02552888","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Jing","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana"},{"name":"Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"},{"name":"Department of Medicine, Southeast Louisiana Veterans Health Care System, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. Lee","family":"Hamm","sequence":"additional","affiliation":[{"name":"Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6054-2624","authenticated-orcid":false,"given":"Joshua D.","family":"Bundy","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Damodar R.","family":"Kumbala","sequence":"additional","affiliation":[{"name":"Renal Associates of Baton Rouge, Baton Rouge, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shirisha","family":"Bodana","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Ochsner Health System, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sehgal","family":"Chandra","sequence":"additional","affiliation":[{"name":"Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chung-Shiuan","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlton C.","family":"Starcke","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Tulane 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Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin","family":"Mahone","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aarti M.","family":"Vadalia","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terra","family":"Livingston","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Obst","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana"},{"name":"Tulane University Translational Science Institute, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesus","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7917-952X","authenticated-orcid":false,"given":"Syed Rizwan","family":"Bokhari","sequence":"additional","affiliation":[{"name":"Department of Medicine, Tulane University School of Medicine, New Orleans, 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