Overview

Sodium Nitrite to Treat Arterial Aging

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
The proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. The study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. Overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Colorado, Boulder
Collaborator:
TheraVasc Inc.
Criteria
Inclusion Criteria:

- 50-79 years of age

- Ability to provide informed consent

- Score greater than 22 on the mini mental state exam

- Blood pressure greater than 100/60 mmHg for past 3 months

Exclusion Criteria:

- Are taking any of the following medications/drugs: hormone replacement therapy,
anti-hypertensives, nitrates, nervous system depressants, allopurinol,
phosphodiesterase-5 inhibitors, blood thinners

- Are currently sick/have chronic clinical diseases such as kidney disease, diabetes, or
unstable cardiovascular disease

- Are hypersensitive to nitrates or nitrites

- Have glucose-6-phosphate dehydrogenase deficiency

- Have blood methemoglobin greater than 2%

- Have a BMI greater than 40 kg/m^2

- Have a baseline FMD of greater than 6%

- Have not been post-menopausal for at least 1 year

- Perform regular vigorous aerobic/endurance exercise