Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD: A Randomized Phase 2 Pilot Trial.

Study answer

What this study found

The combination of sodium nitrite and isoquercetin did not significantly improve endothelial function or most biomarker outcomes versus placebo. Flow-mediated vasodilation changed by 1.1% at 12 weeks in the treatment group versus 0.3% with placebo, for a net change of 0.8% (95% confidence interval, 20.1 to 2.5). Changes in biomarkers of endothelial dysfunction, inflammation, and oxidative stress were not significantly different between groups. Safety was similar between groups, although leg swelling was more common in placebo. Overall, the findings do not support routine use of this…

Study & population

Randomized, phase 2 pilot trial in adults with predialysis chronic kidney disease, spanning stages 1 to 5, from the greater New Orleans area.

Intervention

Oral immediate-release sodium nitrite 40 mg twice daily plus isoquercetin 225 mg once daily for 12 weeks, taken at least 30 minutes before eating.

Key limitation

This was a small phase 2 pilot study with a 12 week follow-up, which limits power to detect modest effects and long-term outcomes.

View full study detailsView sourceOpen PDF

Original abstract