NCT02022670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 17, 2015

Completed
Last Updated

July 15, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

December 13, 2013

Results QC Date

March 12, 2015

Last Update Submit

June 18, 2015

Conditions

Vascular Aging

Keywords

endothelial functionarterial stiffnessflow-mediated dilationpulse wave velocitysodium nitriteagingvascular diseases

Outcome Measures

Primary Outcomes (1)

  • Baseline and Week 10 Flow-Mediated Dilation

    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 Outcomes (2)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks

Drug: Placebo

Sodium Nitrite 80 mg/d

EXPERIMENTAL

80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks

Drug: Sodium Nitrite

Sodium Nitrite 160 mg/d

EXPERIMENTAL

160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks

Drug: Sodium Nitrite

Interventions

PlaceboDRUG

Sugar pill manufactured to mimic sodium nitrite capsules

Placebo
Sodium NitriteDRUG

80 mg/d or 160 mg/d

Also known as: TV1001
Sodium Nitrite 160 mg/dSodium Nitrite 80 mg/d

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Translational Research Center

Boulder, Colorado, 80309, United States

Location

Related Links

MeSH Terms

Conditions

Vascular Diseases

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. Allison DeVan
Organization
University of Colorado Boulder
allison.devan@colorado.edu
303-735-6410

Study Officials

  • Douglas R Seals, Ph.D.

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

  • Allison E DeVan, Ph.D.

    University of Colorado, Boulder

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2013

First Posted

December 30, 2013

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 15, 2015

Results First Posted

June 17, 2015

Record last verified: 2015-06

Locations

US(1)