Vascular AgingPhase 1/2NCT02022670
Sodium Nitrite to Treat Arterial Aging
A Phase 1/2 study testing Sodium Nitrite in people with Vascular Aging, run by University of Colorado, Boulder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Aging
- What is being tested?
- Sodium Nitrite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Have a baseline FMD of greater than 6%
- Have not been post-menopausal for at least 1 year
- Perform regular vigorous aerobic/endurance exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Translational Research Center
Boulder, Colorado, 80309
About this study
Official title: Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans
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.
Read the 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 and week 10.
- Conditions
- Vascular Aging
- Being tested
- Placebo, Sodium Nitrite
- Keywords
- endothelial function, arterial stiffness, flow-mediated dilation, pulse wave velocity, sodium nitrite, aging, vascular diseases
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Sugar pill manufactured to mimic sodium nitrite capsules
Sodium NitriteDrug
Also called TV1001
80 mg/d or 160 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks Receives: Drug: Placebo |
| Sodium Nitrite 80 mg/d | Experimental | 80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks Receives: 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 Receives: Drug: Sodium Nitrite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Week 10
Secondary outcomes (2)
Baseline and Week 10 Plasma Nitrite Concentrations
Measured: Baseline (Week 0), Week 10
Baseline and Week 10 Aortic Pulse Wave Velocity
Measured: Baseline (Week 0), Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- TheraVasc Inc.
- Responsible party
- Sponsor
- Investigators
- Douglas R Seals, Ph.D., Principal investigator, University of Colorado, BoulderAllison E DeVan, Ph.D., Study director, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022670
- Sponsor's protocol ID
- R21HL107105
- Status last verified
- Jun 2015
- First submitted
- 13 Dec 2013
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Translation of Nitrite Therapy to Treat Arterial Aging in Humans
- ClinicalTrials.gov ID
- NCT02022670
- Acronym / sponsor ID
- R21HL107105
- Conditions
- Vascular Aging
- Keywords
- endothelial function, arterial stiffness, flow-mediated dilation, pulse wave velocity, sodium nitrite, aging, vascular diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- TheraVasc Inc.
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 17 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and week 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboinert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks |
| Sodium Nitrite 80 mg/d | Experimental | Drug: Sodium Nitrite80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks |
| Sodium Nitrite 160 mg/d | Experimental | Drug: Sodium Nitrite160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSugar pill manufactured to mimic sodium nitrite capsules | Drug | Placebo |
| Sodium NitriteAlso: TV100180 mg/d or 160 mg/d | Drug | Sodium Nitrite 160 mg/d, Sodium Nitrite 80 mg/d |
Primary outcome
Baseline and Week 10 Flow-Mediated Dilation
Time frame: Baseline (Week 0), Week 10
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.
2 secondary outcomes
Baseline and Week 10 Plasma Nitrite Concentrations
Time frame: Baseline (Week 0), Week 10
Baseline and Week 10 Aortic Pulse Wave Velocity
Time frame: Baseline (Week 0), Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Integrative Physiology of Aging Laboratory WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas R Seals, Ph.D. principal investigator
University of Colorado, Boulder
Allison E DeVan, Ph.D. study director
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sodium Nitrite in people with Vascular Aging, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline and Week 10 Flow-Mediated Dilation (time frame: Baseline (Week 0), Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.