Sodium Nitrite to Treat Arterial Aging

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Colorado, Boulder
Sponsor:
Collaborator:
TheraVasc Inc.
Information provided by (Responsible Party):
University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT02022670
First received: December 13, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Vascular Aging
Drug: Placebo
Drug: Sodium Nitrite
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans

Resource links provided by NLM:


Further study details as provided by University of Colorado, Boulder:

Primary Outcome Measures:
  • Change from Baseline in Flow-Mediated Dilation at Week 4 and Week 10 [ Time Frame: Baseline (Week 0), Week 4, Week 10 ] [ Designated as safety issue: No ]
    Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline, week 4, and week 10.


Secondary Outcome Measures:
  • Change from Baseline in Plasma Nitrite at Week 10 [ Time Frame: Baseline (Week 0), Week 10 ] [ Designated as safety issue: No ]
  • Reduction in Flow-Mediated Dilation to Forearm Ischemia/Reperfusion Injury [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    Brachial artery flow-mediated dilation before and 15 minutes after 20 minutes of forearm ischemia.

  • Change from Baseline Aortic Pulse Wave Velocity at Week 4 and Week 10 [ Time Frame: Baseline (Week 0), Week 4, Week 10 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from Baseline in Blood Methemoglobin at Day 1, Day 2, Week 1, Week 2, Week 4 and Week 10 [ Time Frame: Baseline (Week 0), Day 1, Day 2, Week 1, Week 2, Week 4, Week 10 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 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 Name: 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 Name: TV1001

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, week 4, and week 10.

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022670

Contacts
Contact: Candace Bassett, BA 303-735-6410 ipalab@colorado.edu

Locations
United States, Colorado
Clinical Translational Research Center Recruiting
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02022670     History of Changes
Other Study ID Numbers: R21HL107105
Study First Received: December 13, 2013
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Colorado, Boulder:
endothelial function
arterial stiffness
flow-mediated dilation
pulse wave velocity
sodium nitrite
aging
vascular diseases
reperfusion injury

ClinicalTrials.gov processed this record on September 30, 2014