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Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

NCT06369350 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-17

No results posted yet for this study

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

Interventions

DRUG

Vitamin B6 25 MG

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

DRUG

Vitamin B6 50 MG

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

DRUG

Vitamin B6 100 MG

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

DRUG

Placebo

Placebo capsule will be given for up to 31 days.

Sponsors & Collaborators

Principal Investigators

  • Lu Qin · Penn State College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-12-31
Primary Completion
2028-09-30
Completion
2028-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06369350 on ClinicalTrials.gov