Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults

Phase 1 Completed 11 enrolled Gladwin, Mark, MD

RandomizedCrossoverOpen-labelOther

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.

Timeline

Start: 2012-10
Primary completion: 2013-10
Completion: 2013-10

Publications

Hughan KS, Wendell SG, Delmastro-Greenwood M, Helbling N, Corey C, Bellavia L, Potti G, Grimes G, Goodpaster B, Kim-Shapiro DB, Shiva S, Freeman BA, Gladwin MT. Conjugated Linoleic Acid Modulates Clinical Responses to Oral Nitrite and Nitrate. Hypertension. 2017 Sep;70(3):634-644. doi: 10.1161/HYPERTENSIONAHA.117.09016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Nitrate	Other / unclassified	1000 mg	Oral
Subject	Sodium Nitrite	Small molecule	20 mg	Oral

Indications

No indication recorded.