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The Effects of High-dose Vitamin B6 on Depression and Anxiety Symptoms

NCT07469462 · University of Reading
In plain English

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Official title
An EEG Study to Investigate the Effect of High-dose Vitamin B6 Supplementation on Neural Activity in Relation to Depression and Anxiety Symptoms.
About this study
The primary question this trial aims to answer is: \- Compared to placebo, in people experiencing depression and anxiety symptoms, does high-dose Vitamin B6 supplementation change the excitation/inhibition balance towards inhibition as measured using electroencephalography (EEG)? Secondary research questions are: * Compared to placebo, does high-dose Vitamin B6 supplementation reduce symptoms of depression and anxiety? * Do individuals with lower Vitamin B6 levels at baseline, as measured in blood plasma, show a larger effect of high dose Vitamin B6 on the EEG measures or symptoms? * Compared to placebo, does high-dose Vitamin B6 intervention lead to an increase in hand grip strength? This is a possibility suggested to us by our prvious finding of reduced self reported 'postural disorder' by Vitamin B6 (Field et al., 2024), and by existing literature about the role of Vitamin B6 in muscle function.
Eligibility criteria
Inclusion Criteria: * Over 18 years of age and under 41 * Mild to moderate anxiety and/or depression * Normal or corrected to normal vision Exclusion Criteria: * not taking daily dietary supplement containing \>2 mg Vitamin B6 * not taking medication that is a GABA agaonist (our team will check this with you) * not be pregnant * no medical history of epilepsy * no medical history of peripheral neuropathy * not taking the antibiotic Seromycin (prescribed for tuberclosis or urinary tract infection) * no history of brain injury or recent concussion
Study design
Enrollment target: 44 participants
Allocation: randomized
Masking: double
Age groups: adult
Timeline
Starts: 2026-05-01
Estimated completion: 2026-11
Last updated: 2026-04-28
Interventions
Drug: Pyridoxal-5'-Phosphate supplementDrug: Placebo Supplementation
Primary outcomes
  • Neural inhibition measured using Electroencephalography (From enrolment to the end of treatment 1 week later)
Sponsor
University of Reading · other
With: eBeauty Ltd Innopure, Regus House, Cardiff Gate Business Park, Malthouse Avenue, Cardiff, CF23 8RU
Contacts & investigators
ContactAlex Cameron · contact · a.cameron@pgr.reading.ac.uk · 0118 378 6803
ContactDavid T Field · contact · d.t.field@reading.ac.uk · +44 1183785004
InvestigatorDavid T Field · principal_investigator, University of Reading
All locations (1)
Harry Pitt BuildingRecruiting
Reading, England, United Kingdom
The Effects of High-dose Vitamin B6 on Depression and Anxiety Symptoms · TrialPath