Clinical trial NCT06415383: The Effects of Vitamin B6 Supplementation on Pain Thresholds and Tolerance
Official title: Testing the Effects of High-dose Vitamin B6 Supplements on Pain Thresholds and Tolerance in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pain
Keywords: Vitamin B6
GABA
Excitation-Inhibition balance
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: INNOPURE
First posted: 2024-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

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

Primary outcomes:
measure: Thermal sensory threshold
timeFrame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Thermal pain threshold
timeFrame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Electrical pain sensitivity
timeFrame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Thermal pain tolerance
timeFrame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Cold immersion pain tolerance
timeFrame: This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Pain wind-up
timeFrame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Secondary outcomes:
measure: State anxiety
timeFrame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Positive and negative affect
timeFrame: This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Sleep quality
timeFrame: This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention
measure: Dietary intake
timeFrame: This will be measured at baseline during their first visit only
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References:
citation: Spielberger, C. D., Gonzalez-Reigosa, F., Martinez-Urrutia, A., Natalicio, L. F., & Natalicio, D. S. (1971). The state-trait anxiety inventory. Revista Interamericana de Psicologia/Interamerican journal of psychology, 5(3 & 4).
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Martinez-Gonzalez MA, Garcia-Arellano A, Toledo E, Salas-Salvado J, Buil-Cosiales P, Corella D, Covas MI, Schroder H, Aros F, Gomez-Gracia E, Fiol M, Ruiz-Gutierrez V, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Munoz MA, Warnberg J, Ros E, Estruch R; PREDIMED Study Investigators. A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial. PLoS One. 2012;7(8):e43134. doi: 10.1371/journal.pone.0043134. Epub 2012 Aug 14.