The Effects of Vitamin B6 Supplementation on Pain Thresholds and Tolerance
NCT ID: NCT06415383
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-05-30
2025-03-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vitamin-B6
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).
Vitamin B6 100 MG
Vitamin B6 in for the form of pyridoxal phosphate (PLP)
Placebo
Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month.
Placebo
Placebo tablet containing microcrystalline cellulose
Interventions
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Vitamin B6 100 MG
Vitamin B6 in for the form of pyridoxal phosphate (PLP)
Placebo
Placebo tablet containing microcrystalline cellulose
Eligibility Criteria
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Inclusion Criteria
* Fluent speaker of English language
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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INNOPURE
UNKNOWN
University of Reading
OTHER
Responsible Party
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David Field
Associate professor
Locations
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University of Reading
Reading, Berkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David T Field, PhD
Role: primary
References
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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.
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.
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.
Other Identifiers
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UREC24/13
Identifier Type: -
Identifier Source: org_study_id