Not Yet RecruitingEarly Phase 1

Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

30 participantsStarted 2027-12

Plain-language 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. 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.

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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: * a detailed medical history * complete physical examination (including vital signs) * a blood pressure that is within a safe range (\<150/100mmHg) Exclusion Criteria: * \< 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 * 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 Disor…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

baseline blood pressure in mmHg

Timeframe: Recorded continuously for up to 4 hours during the study visit

Second visit blood pressure in mmHg

Timeframe: 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

Timeframe: Recorded continuously for up to 4 hours during the study visit

Second visit heart Rate in beats per minute

Timeframe: 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

Timeframe: Recorded continuously for up to 4 hours during the study visit

Second visit muscle sympathetic nerve activity in burst/min

Timeframe: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))

Trial details

NCT IDNCT06369350

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Lu Qin, PhD

7175317483 lqin@pennstatehealth.psu.edu

View on ClinicalTrials.gov More Ischemia Reperfusion Injury trials

Plain-language summary

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

baseline blood pressure in mmHg

Timeframe: Recorded continuously for up to 4 hours during the study visit

Second visit blood pressure in mmHg

Timeframe: 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

Timeframe: Recorded continuously for up to 4 hours during the study visit

Second visit heart Rate in beats per minute

Timeframe: 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

Timeframe: Recorded continuously for up to 4 hours during the study visit

Second visit muscle sympathetic nerve activity in burst/min

Timeframe: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))