University of Reading
Reading, RG6 6AL, United Kingdom
Location status: Recruiting
NCT Number: NCT06234501
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Reading, RG6 6AL, United Kingdom
Location status: Recruiting
The main question it aims to answer is:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 mg Pyridoxal 5'-Phosphate tablet once daily with food
Other names: Vitamin B6
Placebo tablet once daily
Other names: Control group
Time frame: Baseline and One month
Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D.
Time frame: Baseline and One month
Sensory hyperreactivity will be measured by a subscale of the Comprehensive Autistic Trait Inventory (CATI).
Time frame: Baseline and One month
Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire.
Time frame: Baseline and One month
The concentration of different forms of Vitamin B6 in blood plasma will be measured (Pyridoxal-5'-phosphate, pyridoxine, pyridoxal, pyridoxamine)
Time frame: Baseline and One month
Adult Attention Deficit Hyperreactivity Disorder Self-Report Scale (ASRS-v1.1)
Time frame: Baseline and One month
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.
Time frame: Baseline and One month
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and One month
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).
Time frame: Baseline and One month
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).
Time frame: Baseline and One month
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).
Time frame: Baseline and One month
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).
Time frame: Baseline and One month
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.
Time frame: Baseline and One month
Magnitude of the tilt illusion is a correlate of GABA concentration in the occipital cortex (Song et al., 2017).
Time frame: Baseline and One month
Magnitude of the Ebbinghaus illusion is a correlate of gamma y-Aminobutyric acid (GABA) concentration in the parietal lobe (Song et al. 2017)
Contact information is provided by the study sponsor or research team.
Alex Cameron, MSc
CONTACT
Dr David T Field, PhD
CONTACT
University of Reading
Other
Testing the Potential of High-dose Vitamin B6 Supplements for Sensory Reactivity in Autism
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