Sodium Nitrite to Treat Arterial Aging

Phase 1

Completed

• Conditions: Vascular Aging
• Interventions: Drug: Sodium Nitrite; Drug: Placebo

• Registration Number: NCT02022670
• Lead Sponsor: University of Colorado, Boulder

Brief 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Results First Submitted: 2015-03-12
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-01
• Results First Posted: 2015-06-17
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Nitrite 160 mg/d	Sodium Nitrite	160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Placebo	Placebo	inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks
Sodium Nitrite 80 mg/d	Sodium Nitrite	80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks

Primary Outcome Measures

Name	Time	Method
Baseline and Week 10 Flow-Mediated Dilation	Baseline (Week 0), Week 10	Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.

Secondary Outcome Measures

Name	Time	Method
Baseline and Week 10 Plasma Nitrite Concentrations	Baseline (Week 0), Week 10
Baseline and Week 10 Aortic Pulse Wave Velocity	Baseline (Week 0), Week 10

Trial Locations

Locations (1)

Clinical Translational Research Center; 🇺🇸 Boulder, Colorado, United States