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OpenTrials
Completed

NCT Number: NCT02022670

Sodium Nitrite to Treat Arterial Aging

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.

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Key information

Conditions

Vascular Aging Cardiovascular Diseases Vascular Diseases

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Translational Research Center

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Sugar pill manufactured to mimic sodium nitrite capsules

Sodium Nitrite

Drug

80 mg/d or 160 mg/d

Other names: TV1001

Primary outcomes

  1. 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 outcomes

  1. Baseline and Week 10 Plasma Nitrite Concentrations

    Time frame: Baseline (Week 0), Week 10

  2. Baseline and Week 10 Aortic Pulse Wave Velocity

    Time frame: Baseline (Week 0), Week 10

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • TheraVasc Inc.

Registry information

Official study title

Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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