NCT06369350

Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion

Effects of Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Ischemia Reperfusion Injury
• Peripheral Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2027-12-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-04-17
• Last updated: 2026-03-17

Regulatory

• FDA-regulated drug study