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NCT01684930 · ClinicalTrials.gov registry record · Phase 2
Nitrites, Exercise, and Peripheral Arterial Disease
A Phase 2 study of Peripheral Arterial Disease, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01684930: Completed Phase 2 study of Peripheral Arterial Disease, sponsored by Duke University.
NCT01684930 is a Phase 2 study of Peripheral Arterial Disease that has completed, run by Duke University. The registered enrollment target is 32 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01684930, a Phase 2 study of Peripheral Arterial Disease, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).
Primary Outcome
Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.
Conditions Studied
Interventions
- DRUG Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training
- OTHER Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training
Study Locations (1)
North Carolina
- Duke Diet & Fitness Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01684930 record still lists
NCT01684930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training is the first listed.
NCT01684930 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01684930 about?
NCT01684930 is a clinical study titled "Nitrites, Exercise, and Peripheral Arterial Disease". The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and ...
What is the current status of trial NCT01684930?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2012-06. Estimated completion is 2014-11.
What conditions does trial NCT01684930 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT01684930?
The interventions under investigation include: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training (DRUG), Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training (OTHER).
Who is sponsoring clinical trial NCT01684930?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01684930 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01684930's enrollment target sits among peer trials
32 58th of 79 higher than 22 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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