Ischemia Reperfusion InjuryEarly Phase 1NCT06369350
Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion
A Early Phase 1 study testing Vitamin B6 25 MG, Vitamin B6 50 MG and Vitamin B6 100 MG in people with Ischemia Reperfusion Injury and Peripheral Artery Disease, run by Milton S. Hershey Medical Center.
Trial summary
In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemia Reperfusion Injury, Peripheral Artery Disease
- What is being tested?
- Vitamin B6 25 MG, Vitamin B6 50 MG and Vitamin B6 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2027to Sep 2028
- Phase
- Early Phase 1
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are males and females at least 21- 70 years of age (inclusive)
- Capable of giving informed consent
- Are of any race or ethnicity
- Can communicate in English
- Females may be on oral contraceptives but will be excluded if they are pregnant or lactating
- Healthy Status as defined by the absence of evidence of any active or chronic disease as determined by the following:
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- a detailed medical history
- complete physical examination (including vital signs)
- a blood pressure that is within a safe range (<150/100mmHg)
Who cannot join
- < 21 years of age or > 70 years of age
- Pregnant or nursing woman
- Prisoners or institutionalized individuals unable to consent
- Decisional impairment
- Not able to communicate in English.
- Current smoker
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- Have any clinically relevant history or the presence of metabolic (e.g., diabetes), respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or other disease or diseases that, in the opinion of the research team, exclude the subject from participation.
- Presenting with a resting blood pressure of 150/100 or higher
- Taking any medications that affect vascular control or autonomic function (e.g. beta blockers, ACE inhibitors, calcium channel blockers, etc.)
- Taking a multivitamin with B6, a B-complex vitamin, or vitamin B-6 at baseline, with a history of Parkinson's disease, and taking levodopa
- Known allergy or hypersensitivity to Vitamin B6
- Opioid Use Disorder or on opioid therapy
- Subject has a recent drug or alcohol abuse history (less than 6 months) or is currently using or abusing excessive alcohol or drugs. Excessive alcohol will be defined as greater than 14 drinks per week. Use of recreational drugs in the past 6 months is also an exclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion
In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients.
Read the detailed description
The Ischemia-reperfusion (IR) injury is caused by a burst of reactive oxygen species (ROS) production during reperfusion, which leads to cell damage and inflammation and further exacerbates the underlying ischemic condition. PAD patients endure this pathological condition during various situations of this disease. In a hindlimb IR model, the blood flow in the lower extremity of the plantar muscle and gastrocnemius muscle reduced at 6 h after the femoral artery ligation and gradually restores at 18, 66 and 114 h after the blood flow reperfusion in the femoral artery. Meanwhile, the mean arterial pressure (MAP) responses to static muscle contraction increased in the above blood reperfusion time courses. Examining the underlying mechanisms leading to the exaggerated EPR in the IR injury of PAD will be essential to provide a fundamental base for developing effective interventions to prevent or alleviate the PAD-associated symptoms and complications. The P2X3 receptor in DRG is a potential candidate for regulating this exaggerated EPR in IR. Vitamin B6 can function as a blockade for the P2 receptors. Therefore, we hypothesize it will attenuate the exaggerated exercise pressor reflex (EPR) in the experimental lower limb IR procedure on healthy human participants.
- Being tested
- Vitamin B6 25 MG, Vitamin B6 50 MG, Vitamin B6 100 MG, Placebo
- Medical subject headings
- Reperfusion Injury, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B6 25 MGDrug
Vitamin B6 25 mg/day will be given for up to 31 days.
Vitamin B6 50 MGDrug
Vitamin B6 50 mg/day will be given for up to 31 days.
Vitamin B6 100 MGDrug
Vitamin B6 100 mg/day will be given for up to 31 days.
PlaceboDrug
Placebo capsule will be given for up to 31 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Vitamin B6 25mg | Active comparator | Not described Receives: Drug: Vitamin B6 25 MG |
| Vitamin B6 50mg | Active comparator | Not described Receives: Drug: Vitamin B6 50 MG |
| Vitamin B6 100mg | Active comparator | Not described Receives: Drug: Vitamin B6 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline blood pressure in mmHg
Measured: Recorded continuously for up to 4 hours during the study visit
Second visit blood pressure in mmHg
Measured: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
baseline heart Rate in beats per minute
Measured: Recorded continuously for up to 4 hours during the study visit
Second visit heart Rate in beats per minute
Measured: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
baseline muscle sympathetic nerve activity in burst/min
Measured: Recorded continuously for up to 4 hours during the study visit
Second visit muscle sympathetic nerve activity in burst/min
Measured: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
baseline walking time in minutes
Measured: Recording walking time to fatigue (up to 22 minutes maximum) during the study visit
Second visit walking time in minutes
Measured: Recording walking time to fatigue (up to 22 minutes maximum) during the second visit (up to 31 days after the first visit))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startDec 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia Reperfusion InjuryStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Lu Qin, Milton S. Hershey Medical Center
- Investigators
- Lu Qin, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369350
- Sponsor's protocol ID
- STUDY000020217
- Other IDs
- 940567
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No