NCT02022670

Sodium Nitrite to Treat Arterial Aging

Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed description

The improvement in blood vessel function and stiffness will be determined over a 10 week period. Subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day) or high dose (160 mg/day) sodium nitrite. Main outcome measures will be performed at baseline and week 10.

Conditions

• Vascular Aging

Interventions

Type	Name	Description
DRUG	Placebo	Sugar pill manufactured to mimic sodium nitrite capsules
DRUG	Sodium Nitrite	80 mg/d or 160 mg/d

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-12-30
• Last updated: 2015-07-15
• Results posted: 2015-06-17

Locations

1 site across 1 country: United States