The Effects of High-dose Vitamin B6 on Depression and Anxiety Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-41
SponsorUniversity of Reading
About this trial
This clinical trial investigates the effects of Vitamin B6 supplementation on neural inhibition using electroencephalography (EEG), in relation to depression and anxiety symptoms in participants from the general population with a relatively high level of symptoms at baseline. Researchers will compare a placebo group to high-dose Vitamin B6 to test the hypothesis that Vitamin B6 moves the excitation/inhibition balance towards inhibition.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Over 18 years of age and under 41
Mild to moderate anxiety and/or depression
Normal or corrected to normal vision
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pyridoxal-5'-Phosphate supplement
Drug100mg PLP in the form of a tablet, taken once a day for 1 week
Placebo Supplementation
DrugPlacebo supplement in the form of a capsule.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Pyridoxal-5'-Phosphate supplementExperimental treatment 1 intervention
Group B: Microcrystalline Cellulose PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neural inhibition measured using Electroencephalography
Time frame
From enrolment to the end of treatment 1 week laterSecondary outcomes
1
Self-reported depression symptoms (Depression, Anxiety, and Stress questionnire, DASS)
Time frame
From enrolment to the end of treatment 1 week later2
Self reported anxiety (Screen for Adult Anxiety Related Disorders, SCAARED)
Time frame
From enrolment to the end of treatment 1 week later3
Hand grip strength
Time frame
From enrolment to the end of treatment 1 week later4
Vitamin B6 status
We will quantify Vitamin B6 in capillary blood samples
Time frame
From enrolment to the end of treatment 1 week laterSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Reading
Lead sponsor
eBeauty Ltd Innopure, Regus House, Cardiff Gate Business Park, Malthouse Avenue, Cardiff, CF23 8RU
Collaborator
Source ClinicalTrials.gov