Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

Launched by MILTON S. HERSHEY MEDICAL CENTER · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether vitamin B6 can help reduce high blood pressure that some people experience during exercise, especially after a condition called ischemia-reperfusion injury, which affects blood flow to the legs. The researchers are particularly interested in a specific protein in the body, known as P2X3, which is important for controlling blood pressure. By understanding how vitamin B6 interacts with this protein, the study aims to find new ways to improve health and well-being for patients with peripheral artery disease (PAD).

To participate in this study, individuals must be between 21 and 70 years old, in good health, and able to communicate in English. They should not have any serious health conditions or take medications that could affect blood pressure. Participants will be closely monitored to ensure their safety throughout the trial. This study is not yet recruiting, but it could lead to important discoveries that benefit many patients dealing with blood pressure issues related to exercise.

Gender

ALL

Eligibility criteria

• 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 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.