Sodium Nitrite to Treat Arterial Aging

June 18, 2015 updated by: University of Colorado, Boulder

Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • Clinical Translational Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks
Drug: Placebo
Sugar pill manufactured to mimic sodium nitrite capsules
EXPERIMENTAL: Sodium Nitrite 80 mg/d
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Drug: Sodium Nitrite
80 mg/d or 160 mg/d
Other Names:
  • TV1001
EXPERIMENTAL: Sodium Nitrite 160 mg/d
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Drug: Sodium Nitrite
80 mg/d or 160 mg/d
Other Names:
  • TV1001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 0), Week 10

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Boulder

Collaborators

TheraVasc Inc.

Investigators

  • Principal Investigator: Douglas R Seals, Ph.D., University of Colorado, Boulder
  • Study Director: Allison E DeVan, Ph.D., University of Colorado, Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

December 13, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (ESTIMATE)

December 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2015

Last Update Submitted That Met QC Criteria

June 18, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R21HL107105 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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