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Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial

NCT02552888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-04-20

Study results available
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Summary

The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease.

Conditions

Interventions

DRUG

Immediate release sodium nitrite

Immediate release sodium nitrite 40 mg by mouth twice per day

DIETARY_SUPPLEMENT

Isoquercetin

Isoquercetin 225 mg by mouth once per day

OTHER

placebos

placebos

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Tulane University

    lead OTHER

Principal Investigators

  • Jing Chen, MD · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-06-30
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02552888 on ClinicalTrials.gov