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| Name | Class |
|---|---|
| INNOPURE | UNKNOWN |
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This clinical trial aims to explore the effect of Vitamin B6 supplementation on anxiety sensory hyperreactivity in autistic adults. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 reduce anxiety and sensory reactivity differences in autism.
The main question it aims to answer is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin-B6 | Experimental | 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) |
|
| Placebo | Placebo Comparator | Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyridoxal 5'-Phosphate (100 mg) | Dietary Supplement | 100 mg Pyridoxal 5'-Phosphate tablet once daily with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensory hyperreactivity | Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D. | Baseline and One month |
| Sensory hyperreactivity | Sensory hyperreactivity will be measured by a subscale of the Comprehensive Autistic Trait Inventory (CATI). | Baseline and One month |
| Anxiety | Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire. | Baseline and One month |
| Vitamin B6 status | The concentration of different forms of Vitamin B6 in blood plasma will be measured (Pyridoxal-5'-phosphate, pyridoxine, pyridoxal, pyridoxamine) | Baseline and One month |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD traits | Adult Attention Deficit Hyperreactivity Disorder Self-Report Scale (ASRS-v1.1) | Baseline and One month |
| Sensory processing differences | These will be measured using the other subscales of the Sensory Processing Inventory (SP3D) that do not constitute the primary sensory hyperreactivity outcome described above. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr David T Field, PhD | Contact | +441183785004 | d.t.field@reading.ac.uk | |
| Alex Cameron, MSc | Contact | a.cameron@pgr.reading.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Dr David T Field, PhD | University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading | Recruiting | Reading | RG6 6AL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20220012 | Background | Yoon JH, Maddock RJ, Rokem A, Silver MA, Minzenberg MJ, Ragland JD, Carter CS. GABA concentration is reduced in visual cortex in schizophrenia and correlates with orientation-specific surround suppression. J Neurosci. 2010 Mar 10;30(10):3777-81. doi: 10.1523/JNEUROSCI.6158-09.2010. | |
| 31451579 | Background | Mentch J, Spiegel A, Ricciardi C, Robertson CE. GABAergic Inhibition Gates Perceptual Awareness During Binocular Rivalry. J Neurosci. 2019 Oct 16;39(42):8398-8407. doi: 10.1523/JNEUROSCI.0836-19.2019. Epub 2019 Aug 26. |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011732 | Pyridoxal Phosphate |
| D025101 | Vitamin B 6 |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D011730 | Pyridoxal |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Other | Placebo tablet once daily |
|
|
| Baseline and One month |
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | Baseline and One month |
| Visual Surround Suppression of contrast perception | Psychophysical measurements of the contrast threshold will be made, which correspond to the minimum physical stimulus contrast that can be reliably detected by an observer. The test measures the increase in the threshold caused by introducing spatial inhibition of the target stimuli, which is a parameter that has been shown to correlate with GABA concentration in the brain (Yoon et al., 2010). | Baseline and One month |
| Surround Suppression of Motion duration detection thresholds | Psychophysical measurements of the motion duration threshold will be made, which correspond to the number of milliseconds an observer requires to detect whether a Gabor patch is drifting left or right. The test measures the increase in the threshold caused by spatial inhibition, which is a parameter that has been shown to differ in various patient groups, including autism (Foss-Feig et al. 2013). | Baseline and One month |
| Binocular Rivalry reversal rate | A test based on presenting ambiguous visual stimuli that cause perceptual reversals; how frequently the perceptual reversals occur is measured and has been shown to be related to GABA levels (Mentch et al., 2019). | Baseline and One month |
| Binocular Rivalry suppression index | A test based on presenting ambiguous visual stimuli that cause perceptual reversals; the proportion of time for which the stimulus appears unclear rather than stable is measured and has been shown to be related to GABA levels (Mentch et al., 2019). | Baseline and One month |
| Measurement of Weber Fraction for size perception | The Weber fraction is the percentage change in a physical quantity required for an observer to reliably detect that a change has occurred, and for a specific stimulus type it is generally a fixed percentage regardless of the magnitude of the stimuli. We will measure the Weber Fraction for visual size perception at four separate starting sizes, and the outcome measure derived from doing that will be a measurement of the stability/instability of the Weber Fraction across the four starting sizes. It has been reported that in autism the general finding of fixed Weber fractions across a range of physical stimuli does not hold (Hadad & Schwartz, 2019): we are taking the opportunity to replicate this finding. | Baseline and One month |
| Tilt illusion magnitude | Magnitude of the tilt illusion is a correlate of GABA concentration in the occipital cortex (Song et al., 2017). | Baseline and One month |
| Ebbinghaus illusion magnitude | Magnitude of the Ebbinghaus illusion is a correlate of gamma y-Aminobutyric acid (GABA) concentration in the parietal lobe (Song et al. 2017) | Baseline and One month |
| 28821653 | Background | Song C, Sandberg K, Andersen LM, Blicher JU, Rees G. Human Occipital and Parietal GABA Selectively Influence Visual Perception of Orientation and Size. J Neurosci. 2017 Sep 13;37(37):8929-8937. doi: 10.1523/JNEUROSCI.3945-16.2017. Epub 2017 Aug 14. |
| 30829198 | Background | Hadad BS, Schwartz S. Perception in autism does not adhere to Weber's law. Elife. 2019 Mar 4;8:e42223. doi: 10.7554/eLife.42223. |
| 23658163 | Background | Foss-Feig JH, Tadin D, Schauder KB, Cascio CJ. A substantial and unexpected enhancement of motion perception in autism. J Neurosci. 2013 May 8;33(19):8243-9. doi: 10.1523/JNEUROSCI.1608-12.2013. |
| D006571 |
| Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |