Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

NCT06369350 | Not Yet Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY000020217940567
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ischemia Reperfusion Injury; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (8)

• baseline blood pressure in mmHg

  Recorded continuously for up to 4 hours during the study visit

• Second visit blood pressure in mmHg

  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

  Recorded continuously for up to 4 hours during the study visit

• Second visit heart Rate in beats per minute

  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

  Recorded continuously for up to 4 hours during the study visit

• Second visit muscle sympathetic nerve activity in burst/min

  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

  Recording walking time to fatigue (up to 22 minutes maximum) during the study visit

• Second visit walking time in minutes

  Recording walking time to fatigue (up to 22 minutes maximum) during the second visit (up to 31 days after the first visit))

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Vitamin B6 25mg

ACTIVE COMPARATOR

Drug: Vitamin B6 25 MG

Vitamin B6 50mg

ACTIVE COMPARATOR

Drug: Vitamin B6 50 MG

Vitamin B6 100mg

ACTIVE COMPARATOR

Drug: Vitamin B6 100 MG

Interventions

Vitamin B6 25 MG DRUG

Vitamin B6 25 mg/day will be given for up to 31 days.

Vitamin B6 25mg

Vitamin B6 50 MG DRUG

Vitamin B6 50 mg/day will be given for up to 31 days.

Vitamin B6 50mg

Vitamin B6 100 MG DRUG

Vitamin B6 100 mg/day will be given for up to 31 days.

Vitamin B6 100mg

Placebo DRUG

Placebo capsule will be given for up to 31 days.

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• American Heart Association: collaborator

MeSH Terms

Conditions

Reperfusion Injury; Peripheral Arterial Disease

Interventions

Vitamin B 6

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lu Qin

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Qin, PhD

CONTACT

7175317483; lqin@pennstatehealth.psu.edu

Kris Gray, MS

CONTACT

7175314589; kgray1@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Department of Medicine

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03