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Vitamin B6 may tame blood pressure spikes during exercise in leg artery disease

NCT ID NCT06369350

Symptom relief Sponsor: Milton S. Hershey Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests whether taking vitamin B6 for up to 31 days can reduce the sharp rise in blood pressure that happens during exercise after a temporary lack of blood flow (like a leg injury). Researchers will measure blood pressure, heart rate, nerve activity, and walking time in 30 healthy adults. The goal is to see if this cheap, non-invasive vitamin could one day help people with peripheral artery disease exercise more comfortably.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vitamin B6
What this could lead to
If it works, this could point toward a simple, low-cost way to help people with peripheral artery disease exercise more safely.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. It only looks at short-term blood pressure changes, not long-term benefits or risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2027

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ischemia reperfusion injury peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemia reperfusion injury Peripheral artery disease

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.