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| Name | Class |
|---|---|
| eBeauty Ltd Innopure, Regus House, Cardiff Gate Business Park, Malthouse Avenue, Cardiff, CF23 8RU | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyridoxal-5'-Phosphate supplement | Experimental | 100mg Vitamin B6 as pyridoxal-5-phosphate, daily with food |
|
| Microcrystalline Cellulose Placebo | Placebo Comparator | Placebo capsule, daily with food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyridoxal-5'-Phosphate supplement | Drug | 100mg PLP in the form of a tablet, taken once a day for 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neural inhibition measured using Electroencephalography | From enrolment to the end of treatment 1 week later |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported depression symptoms (Depression, Anxiety, and Stress questionnire, DASS) | From enrolment to the end of treatment 1 week later | |
| Self reported anxiety (Screen for Adult Anxiety Related Disorders, SCAARED) | From enrolment to the end of treatment 1 week later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Cameron | Contact | 0118 378 6803 | a.cameron@pgr.reading.ac.uk | |
| David T Field | Contact | +44 1183785004 | d.t.field@reading.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| David T Field | University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harry Pitt Building | Recruiting | Reading | England | RG6 6ES | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35851507 | Background | Field DT, Cracknell RO, Eastwood JR, Scarfe P, Williams CM, Zheng Y, Tavassoli T. High-dose Vitamin B6 supplementation reduces anxiety and strengthens visual surround suppression. Hum Psychopharmacol. 2022 Nov;37(6):e2852. doi: 10.1002/hup.2852. Epub 2022 Jul 19. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Placebo Supplementation | Drug | Placebo supplement in the form of a capsule. |
|
| Hand grip strength | From enrolment to the end of treatment 1 week later |
| Vitamin B6 status | We will quantify Vitamin B6 in capillary blood samples | From enrolment to the end of treatment 1 week later |