The Effects of Vitamin B6 Supplementation on Pain Thresholds and Tolerance

University of Reading

Status and phase: Enrolling; Phase 1

Conditions: Pain

Treatments: Other: Placebo; Drug: Vitamin B6 100 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06415383

UREC24/13

Details and patient eligibility

About

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.

Full description

The main questions it aims to answer are:

• How does vitamin B6 affect pain thresholds and tolerance following a single 100mg dose?
• How does vitamin B6 affect pain thresholds following daily supplementation for up to a month?
• Does vitamin B6 supplementation affect measures related to the experience of pain, such as state anxiety, sleep, diet, and mood at different time points

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Vitamin-B6

Experimental group

Description:

Participants will consume one high-dose Vitamin B6 100 mg tablet orally once daily for one month. Vitamin B6 will be provided as Pyridoxal-5'-Phosphate (PLP).

Treatment:

Drug: Vitamin B6 100 MG

Placebo

Placebo Comparator group

Description:

Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month.

Treatment:

Other: Placebo