Clinical trial

Testing the Effects of High-dose Vitamin B6 Supplements on Pain Thresholds and Tolerance in Healthy Adults

ID

Name

UREC24/13

Description

This clinical trial aims to explore the effect of Vitamin B6 supplementation on pain thresholds and tolerance in healthy adults using thermal and electrical stimulation. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 increases pain thresholds and tolerance.

Trial arms

Trial start

2024-05-01

Estimated PCD

2025-12-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Vitamin B6 100 MG

Vitamin B6 in for the form of pyridoxal phosphate (PLP)

Arms:

Vitamin-B6

Placebo

Placebo tablet containing microcrystalline cellulose

Arms:

Placebo

Size

20

Primary endpoint

Thermal sensory threshold

This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention

Thermal pain threshold

This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention

Electrical pain sensitivity

This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention

Thermal pain tolerance

This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention

Cold immersion pain tolerance

This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention

Pain wind-up

This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention

Eligibility criteria

Inclusion Criteria: * Over the age of 18 years * Fluent speaker of English language Exclusion Criteria: * Under 18 years * Presence or history of chronic pain * Presence of neuropathic/nerve pain * Raynaud's syndrome * Using any vitamin supplementations that contain Vitamin B6 at more than the RDA, or combinations of B vitamins. * On any medication that is GABA agonistic * Any use of analgesic/anti-inflammatory medication up to 48 hours prior to any of the testing sessions. * Any heart conditions * Newly acquired tattoos on the pain stimulation site

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-23

1 organization

1 product

1 indication

Organization

University of Reading

Product

Indication