Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06369350
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 17, 2024
Start date
Dec 31, 2027
Status verified
Mar 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo
  • Active Comparator: Vitamin B6 25mg
  • Active Comparator: Vitamin B6 50mg
  • Active Comparator: Vitamin B6 100mg

Primary Outcome Measure

baseline blood pressure in mmHg [ Time Frame: Recorded continuously for up to 4 hours during the study visit ]

Central Contacts

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