NCT02552888

Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 21 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Investigators will recruit 70 albuminuric CKD patients and randomly assign participants to combination therapy with sodium nitrite and isoquercetin or placebo for three months.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-09-17
• Last updated: 2021-04-20
• Results posted: 2021-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study