Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06234501

Testing the Efficacy of 100mg Vitamin-B6 Daily 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pyridoxal 5'-Phosphate (100 mg)

Dietary Supplement

100 mg Pyridoxal 5'-Phosphate tablet once daily with food

Other names: Vitamin B6

Placebo

Other

Placebo tablet once daily

Other names: Control group

Primary outcomes

  1. Sensory hyperreactivity

    Time frame: Baseline and One month

    Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D.

  2. Sensory hyperreactivity

    Time frame: Baseline and One month

    Sensory hyperreactivity will be measured by a subscale of the Comprehensive Autistic Trait Inventory (CATI).

  3. Anxiety

    Time frame: Baseline and One month

    Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire.

  4. Vitamin B6 status

    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)

Secondary outcomes

  1. ADHD traits

    Time frame: Baseline and One month

    Adult Attention Deficit Hyperreactivity Disorder Self-Report Scale (ASRS-v1.1)

  2. Sensory processing differences

    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.

  3. Sleep quality

    Time frame: Baseline and One month

    Pittsburgh Sleep Quality Index (PSQI)

  4. Visual Surround Suppression of contrast perception

    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).

  5. Surround Suppression of Motion duration detection thresholds

    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).

  6. Binocular Rivalry reversal rate

    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).

  7. Binocular Rivalry suppression index

    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).

  8. Measurement of Weber Fraction for size perception

    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.

  9. Tilt illusion magnitude

    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).

  10. Ebbinghaus illusion magnitude

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Cameron, MSc

CONTACT

[email protected]

Dr David T Field, PhD

CONTACT

[email protected]

+441183785004

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • INNOPURE

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.