Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and nitrite capsules for cardiovascular disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gladwin, Mark, MD; University of Pittsburgh

Criteria

Inclusion Criteria:

• Age 18-60 years

• Systolic blood pressure ≤130 and diastolic blood pressure ≤85 mm Hg

Exclusion Criteria:

• Positive urine pregnancy test or breastfeeding

• Concurrent use of medications affecting glucose or lipid metabolism

• Recent addition or change in dosing of hormonal contraceptive medications (oral contraceptive pill, intrauterine device, DepoProvera)

• Current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent

• Current use of phosphodiesterase 5 inhibitors or organic nitrates

• Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc

• Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes

• Smoker