AutismNCT06234501
Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism
A study testing Pyridoxal 5'-Phosphate (100 mg) in people with Autism, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Autism
- What is being tested?
- Pyridoxal 5'-Phosphate (100 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Nov 2024to 13 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18 to 60
- With a diagnosis of autism
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Cameron, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading
Reading, RG6 6AL
David Field, 0118 378 8523, d.t.field@reading.ac.uk
About this study
Official title: 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.
Read the 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
- Conditions
- Autism
- Being tested
- Pyridoxal 5'-Phosphate (100 mg), Placebo
- Keywords
- Vitamin B6, Sensory Hyperreactivity, GABA, Excitation-Inhibition Balance, Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridoxal 5'-Phosphate (100 mg)Dietary supplement
Also called Vitamin B6
100 mg Pyridoxal 5'-Phosphate tablet once daily with food
PlaceboOther
Also called Control group
Placebo tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Pyridoxal 5'-Phosphate (100 mg) |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory hyperreactivity
Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D.
Measured: Baseline and One month
Sensory hyperreactivity
Sensory hyperreactivity will be measured by a subscale of the Comprehensive Autistic Trait Inventory (CATI).
Measured: Baseline and One month
Anxiety
Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire.
Measured: 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)
Measured: Baseline and One month
Secondary outcomes (10)
ADHD traits
Adult Attention Deficit Hyperreactivity Disorder Self-Report Scale (ASRS-v1.1)
Measured: 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.
Measured: Baseline and One month
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
Measured: Baseline and One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start8 Nov 2024
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- INNOPURE
- Responsible party
- Principal investigator, David Field, University of Reading
- Investigators
- Dr David T Field, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234501
- Sponsor's protocol ID
- UREC23/27
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20220012Mentch 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.
PubMed 31451579Song 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.
PubMed 28821653Hadad BS, Schwartz S. Perception in autism does not adhere to Weber's law. Elife. 2019 Mar 4;8:e42223. doi: 10.7554/eLife.42223.
PubMed 30829198Foss-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.
PubMed 23658163