Phase 2
Completed N=33
Sodium Nitrite to Treat Arterial Aging
Source: ClinicalTrials.gov NCT02022670 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Baseline and Week 10 Flow-Mediated Dilation — 3.120; 4.307; 3.118; 3.740 %Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline and Week 10 Flow-Mediated Dilation |
3.120; 4.307; 3.118; 3.740; 6.833; 4.609 | — |
| SECONDARY Baseline and Week 10 Plasma Nitrite Concentrations |
0.201; 0.209; 0.155; 0.261; 0.412; 0.369 | — |
| SECONDARY Baseline and Week 10 Aortic Pulse Wave Velocity |
782; 780; 946; 774; 845; 942 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02022670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.