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Clinical Trial Details

Trial ID: L0341
Source ID: NCT02552888
Associated Drug: Immediate Release Sodium Nitrite
Title: Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial
Acronym: NICE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02552888/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Immediate release sodium nitrite|DIETARY_SUPPLEMENT: Isoquercetin|OTHER: placebos
Outcome Measures: Primary: Mean Percentage Change in Endothelium-dependent Flow-mediated Vasodilation (FMD) Over 12 Weeks, FMD was measured using high resolution ultrasound on the brachial artery. FMD was calculated as the maximal percentage change in vessel size during hyperemia . The mean changes between baseline, 6 weeks and 12 weeks in FMD with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks | Secondary: Mean Change in Endothelial Function Biomarkers VCAM-1, ICAM-1, E-selectin and vWF Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of Vascular Adhesion Molecule-1(VCAM-1), Intercellular Adhesion Molecule-1 (ICAM-1), E-selectin, and von Willebrand Factor (vWF). The mean changes between baseline, 6 weeks and 12 weeks in VCAM-1, ICAM-1, E-selectin and vWF with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Endothelial Function Biomarker Asymmetrical DiMethylArginine (ADMA) Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of Asymmetrical DiMethylArginine (ADMA). The mean changes between baseline, 6 weeks and 12 weeks in ADMA with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Endothelial Function Biomarker Endostatin Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of endostatin. The mean changes between baseline, 6 weeks and 12 weeks in endostatin with 95% CI were calculated using linear mixed effects model, and the log transformed endostatin was calculated., Baseline, 6 weeks, 12 weeks|Mean Change in Endothelial Function Biomarker Urine Epidermal Growth Factor (UEGF) Over 12 Weeks, A urine sample was taken for each participant to measure the levels of Urine Epidermal Growth Factor (UEGF). The mean changes between baseline, 6 weeks and 12 weeks in UEGF with 95% CI were calculated using linear mixed effects model, and the log transformed Urine EGF/creatinine ratio was calculated., Baseline, 6 weeks, 12 weeks|Mean Change in Inflammatory Biomarker C-Reactive Protein (CRP) Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of C-Reactive Protein (CRP). The mean changes between baseline, 6 weeks and 12 weeks in CRP with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Inflammatory Biomarkers Tumor Necrosis Factor-α (TNF-a), Interleukin-17 (IL-17), Interleukin-1β (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1) Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of Tumor Necrosis Factor-α (TNF-a), interleukin-17 (IL-17), interleukin-1β (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1). The mean changes between baseline, 6 weeks and 12 weeks in TNF-a, IL-17, IL-1beta, MCP-1 with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Inflammatory Biomarker Interleukin-6 (IL-6) Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of interleukin-6 (IL-6). The mean changes between baseline, 6 weeks and 12 weeks in interleukin-6 (IL-6) with 95% CI were calculated using linear mixed effects model, and the log transformed IL-6 was calculated., Baseline, 6 weeks, 12 weeks|Mean Change in Oxidative Stress Biomarker Low-density Lipoprotein (LDL) Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of low-density lipoprotein (LDL). The mean changes between baseline, 6 weeks and 12 weeks in LDL with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Oxidative Stress Biomarker Nitrotyrosine Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of nitrotyrosine. The mean changes between baseline, 6 weeks and 12 weeks in nitrotyrosine with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks | Other: Mean Percentage Change in Methemoglobin Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of methemoglobin. The mean percentage change between baseline, 6 weeks and 12 weeks in methemoglobin with 95% CI was calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Isoquercetin Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of isoquercetin. The mean changes between baseline, 6 weeks and 12 weeks in isoquercetin with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Plasma Nitrite Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of plasma nitrite. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrite with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Estimated-Glomerular Filtration Rate (eGFR) Over 12 Weeks, Estimated-Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. The equation is GFR = 141 \* min(Scr/κ,1)α \* max(Scr/κ, 1)-1.209 \* 0.993Age \* 1.018 \[if female\] \* 1.159 \[if black\]. Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. The mean changes between baseline, 6 weeks and 12 weeks in eGFR with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Lipid Profile Biomarkers Total Cholesterol, Low Density Lipoprotein (LDL)-Cholesterol and High Density Lipoprotein (HDL)-Cholesterol Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol. The mean changes between baseline and 12 weeks in total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol with 95% CI were calculated using linear mixed effects model., Baseline,12 weeks|Mean Change in Lipid Profile Biomarker Triglycerides Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of triglycerides. The mean changes between baseline and 12 weeks in triglycerides with 95% CI were calculated using linear mixed effects model, and the log transformed triglyceride was calculated., Baseline,12 weeks|Mean Change in Hemoglobin Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of hemoglobin. The mean changes between baseline, 6 weeks and 12 weeks in hemoglobin with 95% CI were calculated using linear mixed effects model., baseline, 6 weeks, 12 weeks|Mean Change in Plasma Nitrate Over 12 Weeks, A blood sample was drawn for each participant to measure the levels of plasma nitrate. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrate with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Urinary Albumin-to-creatinine Ratios Over 12 Weeks, A urine sample was taken for each participant to measure the levels of urinary albumin-to-creatinine ratios. The mean changes between baseline, 6 weeks and 12 weeks in urinary albumin-to-creatinine ratios with 95% CI were calculated using linear mixed effects model, and the log transformed urinary albumin-to-creatinine ratios was calculated., Baseline, 6 weeks, 12 weeks|Mean Change in Blood Pressure Over 12 Weeks, Blood pressure was measured using the OMRON HEM-907 XL BP Monitor per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in blood pressure with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks|Mean Change in Pulse Over 12 Weeks, Pulse was measured at the brachial artery per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in pulse with 95% CI were calculated using linear mixed effects model., Baseline, 6 weeks, 12 weeks
Sponsor/Collaborators: Sponsor: Tulane University | Collaborators: National Institute of General Medical Sciences (NIGMS)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-03
Completion Date: 2017-06
Results First Posted: 2021-04-20
Last Update Posted: 2021-04-20
Locations: Tulane School of Medicine, New Orleans, Louisiana, 70112, United States
URL: https://clinicaltrials.gov/show/NCT02552888