Health TrialsbyHealthPanel

Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

ConditionsIschemia Reperfusion InjuryPeripheral Artery Disease
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-70
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

< 21 years of age or > 70 years of age

Pregnant or nursing woman

Prisoners or institutionalized individuals unable to consent

Decisional impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin B6 25 MG

    Drug

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

  • Vitamin B6 50 MG

    Drug

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

  • Vitamin B6 100 MG

    Drug

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

  • Placebo

    Drug

    Placebo capsule will be given for up to 31 days.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Vitamin B6 25mgActive comparator 1 intervention
Group C: Vitamin B6 50mgActive comparator 1 intervention
Group D: Vitamin B6 100mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

baseline blood pressure in mmHg

Time frame
Recorded continuously for up to 4 hours during the study visit
2

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))
3

baseline heart Rate in beats per minute

Time frame
Recorded continuously for up to 4 hours during the study visit
4

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))

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

American Heart Association

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: