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| Name | Class |
|---|---|
| TheraVasc Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks |
|
| Sodium Nitrite 80 mg/d | Experimental | 80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks |
|
| Sodium Nitrite 160 mg/d | Experimental | 160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Sugar pill manufactured to mimic sodium nitrite capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas R Seals, Ph.D. | University of Colorado, Boulder | Principal Investigator |
| Allison E DeVan, Ph.D. | University of Colorado, Boulder | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Translational Research Center | Boulder | Colorado | 80309 | United States |
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| Label | URL |
|---|---|
| Integrative Physiology of Aging Laboratory Website | View source |
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Healthy men and women ages 50-79 years free of overt cardiovascular or chronic diseases.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Sugar pill manufactured to mimic sodium nitrite capsules |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Sugar pill manufactured to mimic sodium nitrite capsules |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | %Change | Baseline (Week 0), Week 10 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Sugar pill manufactured to mimic sodium nitrite capsules |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allison DeVan | University of Colorado Boulder | 303-735-6410 | allison.devan@colorado.edu |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012977 | Sodium Nitrite |
| ID | Term |
|---|---|
| D009573 | Nitrites |
| D009608 | Nitrous Acid |
| D017672 | Nitrogen Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium Nitrite |
| Drug |
80 mg/d or 160 mg/d |
|
|
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| Secondary | Baseline and Week 10 Plasma Nitrite Concentrations | Posted | Mean | Standard Error | micromolar | Baseline (Week 0), Week 10 |
|
|
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| Secondary | Baseline and Week 10 Aortic Pulse Wave Velocity | Posted | Mean | Standard Error | cm/sec | Baseline (Week 0), Week 10 |
|
|
|
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | 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 | 0 | 10 | 4 | 10 |
| EG002 | 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 | 0 | 12 | 4 | 12 |
| nausea | General disorders |
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| fatigue | General disorders |
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| dizziness/light-headedness | General disorders |
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| asymptomatic orthostatic hypotension | General disorders |
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| dry mouth | General disorders |
|
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| D017670 |
| Sodium Compounds |
|
|