Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

March 16, 2026 updated by: Lu Qin, Milton S. Hershey Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo capsule will be given for up to 31 days.
Active Comparator: Vitamin B6 25mg
Drug: Vitamin B6 25 MG
Vitamin B6 25 mg/day will be given for up to 31 days.
Active Comparator: Vitamin B6 50mg
Drug: Vitamin B6 50 MG
Vitamin B6 50 mg/day will be given for up to 31 days.
Active Comparator: Vitamin B6 100mg
Drug: Vitamin B6 100 MG
Vitamin B6 100 mg/day will be given for up to 31 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
baseline blood pressure in mmHg
Time Frame: Recorded continuously for up to 4 hours during the study visit
Recorded continuously for up to 4 hours during the study visit
Second visit blood pressure in mmHg
Time Frame: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
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
Time Frame: Recorded continuously for up to 4 hours during the study visit
Recorded continuously for up to 4 hours during the study visit
Second visit heart Rate in beats per minute
Time Frame: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
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
Time Frame: Recorded continuously for up to 4 hours during the study visit
Recorded continuously for up to 4 hours during the study visit
Second visit muscle sympathetic nerve activity in burst/min
Time Frame: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
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
Time Frame: Recording walking time to fatigue (up to 22 minutes maximum) during the study visit
Recording walking time to fatigue (up to 22 minutes maximum) during the study visit
Second visit walking time in minutes
Time Frame: Recording walking time to fatigue (up to 22 minutes maximum) during the second visit (up to 31 days after the first visit))
Recording walking time to fatigue (up to 22 minutes maximum) during the second visit (up to 31 days after the first visit))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lu Qin, Penn State College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY000020217
  • 940567 (Other Grant/Funding Number: American Heart Association)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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