Clinical trial NCT06234501: Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism
Official title: Testing the Potential of High-dose Vitamin B6 Supplements for Sensory Reactivity in Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: Vitamin B6
Sensory Hyperreactivity
GABA
Excitation-Inhibition Balance
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: INNOPURE
First posted: 2024-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The main question it aims to answer is:

* Does high-dose Vitamin B6 supplementation reduce sensory hyperreactivity differences in autism?
* Does high-dose Vitamin B6 supplementation reduce anxiety differences in autism?
* Explore the effects of vitamin B6 on sleep quality, Attention Deficit Hyperactivity Disorder (ADHD) scores, and various visual perception tasks that are indicative of GABAergic activity

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 to 60
* With a diagnosis of autism

Exclusion Criteria:

* Taking any supplement that contains more than 2mg of Vitamin B6 or taking GABA agonist drugs
* Have a medical history of peripheral neuropathy
* lactose intolerance (placebo tablet is lactose based)

Primary outcomes:
measure: Sensory hyperreactivity
timeFrame: Baseline and One month
measure: Sensory hyperreactivity
timeFrame: Baseline and One month
measure: Anxiety
timeFrame: Baseline and One month
measure: Vitamin B6 status
timeFrame: Baseline and One month
Secondary outcomes:
measure: ADHD traits
timeFrame: Baseline and One month
measure: Sensory processing differences
timeFrame: Baseline and One month
measure: Sleep quality
timeFrame: Baseline and One month
measure: Visual Surround Suppression of contrast perception
timeFrame: Baseline and One month
measure: Surround Suppression of Motion duration detection thresholds
timeFrame: Baseline and One month
measure: Binocular Rivalry reversal rate
timeFrame: Baseline and One month
measure: Binocular Rivalry suppression index
timeFrame: Baseline and One month
measure: Measurement of Weber Fraction for size perception
timeFrame: Baseline and One month
measure: Tilt illusion magnitude
timeFrame: Baseline and One month
measure: Ebbinghaus illusion magnitude
timeFrame: Baseline and One month
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
affiliation: University of Reading
name: Dr David T Field, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.