- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06369350
Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion
April 11, 2024 updated by: Lu Qin, Milton S. Hershey Medical Center
Effects of Vitamin B6 on the Exercise Pressor Reflex in Lower Limb Ischemia-Reperfusion
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kris Gray, MS
- Phone Number: 7175314589
- Email: kgray1@pennstatehealth.psu.edu
Study Contact Backup
- Name: Lu Qin, PhD
- Phone Number: 7175317483
- Email: lqin@pennstatehealth.psu.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo capsule will be given for up to 31 days.
|
Active Comparator: Vitamin B6 25mg
|
Vitamin B6 25 mg/day will be given for up to 31 days.
|
Active Comparator: Vitamin B6 50mg
|
Vitamin B6 50 mg/day will be given for up to 31 days.
|
Active Comparator: Vitamin B6 100mg
|
Vitamin B6 100 mg/day will be given for up to 31 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
baseline blood pressure in mmHg
Time Frame: Recorded continuously for up to 4 hours during the study visit
|
Recorded continuously for up to 4 hours during the study visit
|
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))
|
Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
|
baseline heart Rate in beats per minute
Time Frame: Recorded continuously for up to 4 hours during the study visit
|
Recorded continuously for up to 4 hours during the study visit
|
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))
|
Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
|
baseline muscle sympathetic nerve activity in burst/min
Time Frame: Recorded continuously for up to 4 hours during the study visit
|
Recorded continuously for up to 4 hours during the study visit
|
Second visit muscle sympathetic nerve activity in burst/min
Time Frame: Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
|
Recorded continuously for up to 4 hours during the second study visit (up to 31 day after the first visit))
|
baseline walking time in minutes
Time Frame: Recording walking time to fatigue (up to 22 minutes maximum) during the study visit
|
Recording walking time to fatigue (up to 22 minutes maximum) during the study visit
|
Second visit walking time in minutes
Time Frame: Recording walking time to fatigue (up to 22 minutes maximum) during the second visit (up to 31 days after the first visit))
|
Recording walking time to fatigue (up to 22 minutes maximum) during the second visit (up to 31 days after the first visit))
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lu Qin, Penn State College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
April 11, 2024
First Submitted That Met QC Criteria
April 11, 2024
First Posted (Actual)
April 17, 2024
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 11, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Postoperative Complications
- Atherosclerosis
- Peripheral Vascular Diseases
- Ischemia
- Peripheral Arterial Disease
- Reperfusion Injury
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Vitamin B Complex
- Vitamin B 6
- Pyridoxal
- Pyridoxine
Other Study ID Numbers
- STUDY000020217
- 940567 (Other Grant/Funding Number: American Heart Association)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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