The Effects of Vitamin B6 Supplementation on Pain Thresholds and Tolerance

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415383
• Other study ID #: UREC24/13
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Reading
• Contact: David T Field, PhD
• Phone: +441183785004
• Email: d.t.field[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Vitamin B6 100 MG
Vitamin B6 in for the form of pyridoxal phosphate (PLP)

Other:
• Placebo
Placebo tablet containing microcrystalline cellulose

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	INNOPURE

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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).

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal sensory threshold	Sensory threshold will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (0.5 deg C/s) until the participant feels a slight warm sensation. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to perceive a warm sensation will be used as outcome measure. Low values will therefore indicate a high sensitivity to warmth, whereas high values will indicate a low warmth 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
Primary	Thermal pain threshold	Pain threshold will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (1 deg C/s) until the participant feels a slight pain/burning sensation. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to perceive a slight pain/burning sensation will be used as outcome measure. Low values will therefore indicate high pain sensitivity, whereas high values will indicate low 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
Primary	Electrical pain sensitivity	Pain sensitivity will be measured using electrical stimulation. Starting at an initial intensity of 0.3 mA, the intensity of each subsequently applied electrical stimulus will be increased in steps of 0.3 mA each, with a maximum intensity of 10 mA. The procedure will be continued until the participant perceives the applied shock as moderately painful (equivalent to a pain rating of 5 out of 10 or higher). The procedure will be repeated three times. The average intensity (in mA) needed for participants to perceive a moderate pain sensation will be used as outcome measure. Low values will therefore indicate a high sensitivity to electrical stimulation, whereas high values will indicate a low pain sensitivity in response to electrical stimulation.	This will be done at baseline, 4-5 hours, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Primary	Thermal pain tolerance	Pain tolerance will be measured using thermal stimulation (heat stimulation). The starting temperature of the applied probe will be adjusted to the individual's skin temperature and then slowly increased (1 deg C/s) until the participant feels that they can't tolerate the heat anymore. For safety, the temperature will never exceed 50 deg C. The procedure will be repeated three times. The average change in temperature (in degree Celsius) needed for participants to reach their pain tolerance will be used as outcome measure. Low values will therefore indicate low pain tolerance, whereas high values will indicate high 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
Primary	Cold immersion pain tolerance	Pain tolerance will be measured by recording the number of seconds the participant is willing to keep their hand immersed in a 5 degree celsius cold bath, up to a maximum of 120 sec.	This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Primary	Pain wind-up	Pain sensitisation will be measured using a wind-up paradigm (temporal summation) with thermal stimulation (heat simulation).; The thermal probe will start at 32 deg C and increase in temperature (100 deg C/s) to 49 deg C. After a duration of 800 ms, the temperature will return to baseline. Participants will be asked for a pain rating on a scale form 0 (not painful) to 10 (extremely painful). Subsequently, a series of 10 heat stimuli (identical to the once above, ISI 400 ms) will be applied. Participants will be asked to rate the most intense pain that they felt across the series, using the same 0-10 rating scale. The difference in pain ratings in response to the series and to the single stimulus will be used as the outcome measure. Higher (positive) ratings will indicate a stronger sensitisation to repeated painful stimuli. In contrast, negative values will indicate habituation to repeated painful stimuli.	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	State anxiety	State anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which produces a minimum score of 20 and a maximum score of 80, where higher scores indicate greater anxiety.	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	Positive and negative affect	State positive and negative affect will be measured using the The Positive And Negative Affect Schedule Now (PANAS-N) (PANAS-N; adapted from Watson et al., 1988).	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	Sleep quality	Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which results in a score ranging between 0 and 21, where higher scores indicate worse sleep quality.	This will be done at baseline, 3-5 days, 11-13, and 28-35 days after the start of the intervention
Secondary	Dietary intake	Dietary intake will be measured using the Mediterranean Diet Adherence Screener(MEDAS), which produces a score ranging between 0 and 14, where higher scores indicate greater adherence to the Mediterranean diet.	This will be measured at baseline during their first visit only