Sodium Nitrite to Treat Arterial Aging

Overview

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.

Full Title of Study: “Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2013

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.

Interventions

  • Drug: Placebo
    • Sugar pill manufactured to mimic sodium nitrite capsules
  • Drug: Sodium Nitrite
    • 80 mg/d or 160 mg/d

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks
  • Experimental: Sodium Nitrite 80 mg/d
    • 80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
  • Experimental: Sodium Nitrite 160 mg/d
    • 160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Baseline and Week 10 Flow-Mediated Dilation
    • Time Frame: 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 Measures

  • Baseline and Week 10 Plasma Nitrite Concentrations
    • Time Frame: Baseline (Week 0), Week 10
  • Baseline and Week 10 Aortic Pulse Wave Velocity
    • Time Frame: Baseline (Week 0), Week 10

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Colorado, Boulder
  • Collaborator
    • TheraVasc Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Douglas R Seals, Ph.D., Principal Investigator, University of Colorado, Boulder
    • Allison E DeVan, Ph.D., Study Director, University of Colorado, Boulder

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.