Peripheral Artery DiseaseNCT01983826
Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease
A study testing Sodium Nitrate in people with Peripheral Artery Disease, run by University of Iowa at 1 site in United States.
Trial summary
The overarching question addressed in the current project is: Does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (PAD)? The investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Sodium Nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 30 Jun 2016
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented peripheral artery disease
- Ankle-Brachial Index (ABI) < or = to 0.90
Who cannot join
- Non-atherosclerotic vascular disease
- Critical limb ischemia
- Active ischemic ulceration
- Recent (within one year) revascularization
- Symptomatic coronary artery disease (angina pectoris)
- Heart failure
Show all 11Show fewer
- Resting systolic blood pressure > 180 mmHg or diastolic pressure > 100 mmHg
- Hypotension (resting systolic BP < 90 mmHg)
- Smoking or history of smoking within past one year
- Use of phosphodiesterase V inhibitor drugs
- Women with history of hormone replacement therapy within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The overarching question addressed in the current project is: Does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (PAD)? The investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood pressure regulation, and exercise capacity. The proposed project uses an array of clearly defined measurements which will allow investigators to quantify blood vessel function (vasodilator responsiveness and arterial stiffness), blood pressure (variability and responsiveness to stress), and functional capacity before and after 8 weeks of dietary supplementation.
- Conditions
- Peripheral Artery Disease
- Being tested
- Sodium Nitrate, Placebo
- Keywords
- nitrates, blood flow, vascular function, exercise
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitrateDietary supplement
Sodium Nitrate (1g/day) for 8 weeks
PlaceboOther
Microcrystalline cellulose (daily) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sodium Nitrate | Experimental | Sodium Nitrate (1g/day) for 8 weeks Receives: Dietary Supplement: Sodium Nitrate |
| Placebo capsule | Placebo comparator | Microcrystalline cellulose (daily) for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vasodilator Capacity
Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph).
Measured: Pre and post 8 weeks of dietary nitrate supplementation
Change in Arterial Stiffness
ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s).
Measured: Pre and post 8 weeks of dietary nitrate supplementation
Change in Functional Capacity - Distance Walked in 6 Minutes
6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes after 8 weeks of dietary nitrate supplementation.
Measured: Pre and post 8 weeks of dietary nitrate supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Darren P Casey, University of Iowa
- Investigators
- Darren P Casey, Ph.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983826
- Sponsor's protocol ID
- 201307745
- Other IDs
- 13GRNT16490002
- Status last verified
- Feb 2019
- First submitted
- 28 Oct 2013
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hughes WE, Treichler DP, Ueda K, Bock JM, Casey DP. Sodium nitrate supplementation improves blood pressure reactivity in patients with peripheral artery disease. Nutr Metab Cardiovasc Dis. 2022 Mar;32(3):710-714. doi: 10.1016/j.numecd.2021.12.002. Epub 2021 Dec 8.
PubMed 35090799
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT01983826
- Acronym / sponsor ID
- 201307745
- Conditions
- Peripheral Artery Disease
- Keywords
- nitrates, blood flow, vascular function, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Nov 2013
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching question addressed in the current project is: Does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (PAD)? The investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood pressure regulation, and exercise capacity. The proposed project uses an array of clearly defined measurements which will allow investigators to quantify blood vessel function (vasodilator responsiveness and arterial stiffness), blood pressure (variability and responsiveness to stress), and functional capacity before and after 8 weeks of dietary supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Nitrate | Experimental | Dietary Supplement: Sodium NitrateSodium Nitrate (1g/day) for 8 weeks |
| Placebo capsule | Placebo comparator | Other: PlaceboMicrocrystalline cellulose (daily) for 8 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented peripheral artery disease
- Ankle-Brachial Index (ABI) < or = to 0.90
Key exclusion criteria (11 listed)
- Non-atherosclerotic vascular disease
- Critical limb ischemia
- Active ischemic ulceration
- Recent (within one year) revascularization
- Symptomatic coronary artery disease (angina pectoris)
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 |
|---|---|---|
| Sodium NitrateSodium Nitrate (1g/day) for 8 weeks | Dietary supplement | Sodium Nitrate |
| PlaceboMicrocrystalline cellulose (daily) for 8 weeks | Other | Placebo capsule |
Primary outcome
Change in Vasodilator Capacity
Time frame: Pre and post 8 weeks of dietary nitrate supplementation
Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph).
Change in Arterial Stiffness
Time frame: Pre and post 8 weeks of dietary nitrate supplementation
ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s).
Change in Functional Capacity - Distance Walked in 6 Minutes
Time frame: Pre and post 8 weeks of dietary nitrate supplementation
6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes after 8 weeks of dietary nitrate supplementation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35090799Hughes WE, Treichler DP, Ueda K, Bock JM, Casey DP. Sodium nitrate supplementation improves blood pressure reactivity in patients with peripheral artery disease. Nutr Metab Cardiovasc Dis. 2022 Mar;32(3):710-714. doi: 10.1016/j.numecd.2021.12.002. Epub 2021 Dec 8.
Related trials for Peripheral Artery Disease
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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.
Darren P Casey, Ph.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Nitrate in people with Peripheral Artery Disease, run by University of Iowa 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 2 inclusion and 11 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 3 Jun 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). 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?
Change in Vasodilator Capacity (time frame: Pre and post 8 weeks of dietary nitrate supplementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983826, which also lists 1 linked publication.
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 3 Jun 2019.