Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

Starting soon · Early Phase 1 · Has a placebo group

Conditions studied: Ischemia Reperfusion Injury, Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT06369350

Run by

Milton S. Hershey Medical Center

People needed

30

Starts

2027-12-01

Expected to finish

2028-09-01

Last updated by the study team

2026-03-17

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• < 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 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.

Full record on ClinicalTrials.gov

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