Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2011-10-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks
Placebo
Sugar pill manufactured to mimic sodium nitrite capsules
Sodium Nitrite 80 mg/d
80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks
Sodium Nitrite
80 mg/d or 160 mg/d
Sodium Nitrite 160 mg/d
160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks
Sodium Nitrite
80 mg/d or 160 mg/d
Interventions
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Placebo
Sugar pill manufactured to mimic sodium nitrite capsules
Sodium Nitrite
80 mg/d or 160 mg/d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
79 Years
ALL
Yes
Sponsors
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TheraVasc Inc.
INDUSTRY
University of Colorado, Boulder
OTHER
Responsible Party
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Principal Investigators
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Douglas R Seals, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder
Allison E DeVan, Ph.D.
Role: STUDY_DIRECTOR
University of Colorado, Boulder
Locations
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Clinical Translational Research Center
Boulder, Colorado, United States
Countries
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Related Links
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Integrative Physiology of Aging Laboratory Website
Other Identifiers
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