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

NCT06234501 | Recruiting

• 1 other identifier: UREC23/27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Vitamin B6; Sensory Hyperreactivity; GABA; Excitation-Inhibition Balance; Autism

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• ADHD traits

  Baseline and One month

• Sensory processing differences

  Baseline and One month

• Sleep quality

  Baseline and One month

• Visual Surround Suppression of contrast perception

  Baseline and One month

• Surround Suppression of Motion duration detection thresholds

  Baseline and One month

Study Arms (2)

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)

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.

Other: Placebo

Interventions

Pyridoxal 5'-Phosphate (100 mg) DIETARY_SUPPLEMENT

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

Also known as: Vitamin B6

Vitamin-B6

Placebo OTHER

Placebo tablet once daily

Also known as: Control group

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Reading: lead
• INNOPURE: collaborator

Study Sites (1)

University of Reading

Reading, RG6 6AL, United Kingdom

RECRUITING

Related Publications (5)

• 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.

  PMID: 20220012 BACKGROUND

• 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.

  PMID: 31451579 BACKGROUND

• 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.

  PMID: 28821653 BACKGROUND

• 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.

  PMID: 30829198 BACKGROUND

• 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.

  PMID: 23658163 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

Pyridoxal Phosphate; Vitamin B 6; Control Groups

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridoxal; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dr David T Field, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr David T Field, PhD

CONTACT

+441183785004; d.t.field@reading.ac.uk

Alex Cameron, MSc

CONTACT

a.cameron@pgr.reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)