Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism

Testing the Potential of High-dose Vitamin B6 Supplements for Sensory Reactivity in Autism

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.

Study Overview

• Status: Recruiting
• Conditions: Autism
• Intervention / Treatment: Dietary supplement: Pyridoxal 5'-Phosphate (100 mg); Other: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr David T Field, PhD; Phone Number: +441183785004; Email: d.t.field@reading.ac.uk
• Study Contact Backup: Name: Alex Cameron, MSc; Email: a.cameron@pgr.reading.ac.uk

Study Locations

• United Kingdom
  • Reading, United Kingdom, RG6 6AL
    • Recruiting
    • University of Reading
    • Contact: David Field; Phone Number: 0118 378 8523; Email: d.t.field@reading.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin-B6; 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)	Dietary supplement: Pyridoxal 5'-Phosphate (100 mg); 100 mg Pyridoxal 5'-Phosphate tablet once daily with food; Other Names: Vitamin B6
Placebo Comparator: Placebo; Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month.	Other: Placebo; Placebo tablet once daily; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: INNOPURE
• Investigators: Principal Investigator: Dr David T Field, PhD, University of Reading

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: J Neurosci. 2013 Jun 19;33(25):10583.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Autism; Vitamin B6; GABA; Sensory Hyperreactivity; Excitation-Inhibition Balance
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Enzymes and Coenzymes; Coenzymes; Picolines; Pyridoxal; Vitamin B 6; Pyridoxal Phosphate; Control Groups
• Other Study ID Numbers: UREC23/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No