Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

Completed · Phase 1

Conditions studied: Focus of Study of Healthy Adults

In brief

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.

Key facts

Study ID

NCT01681836

Run by

Gladwin, Mark, MD

People needed

11

Starts

2012-10-01

Expected to finish

2013-10-01

Last updated by the study team

2018-09-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-60 years
• Systolic blood pressure ≤130 and diastolic blood pressure ≤85 mm Hg

You may not qualify if…

• 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

Where it is running

• Montefiore Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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