Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pyridoxal 5'-Phosphate (100 mg), Placebo.
- Who it may be relevant to
- Registry conditions: Autism. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Testing the Potential of High-dose Vitamin B6 Supplements for Sensory Reactivity in Autism
Overview
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
Interventions
- Dietary supplement Pyridoxal 5'-Phosphate (100 mg)
100 mg Pyridoxal 5'-Phosphate tablet once daily with food - Other Placebo
Placebo tablet once daily
Primary outcome measures
- Sensory hyperreactivity [Time frame: Baseline and One month]
- Sensory hyperreactivity [Time frame: Baseline and One month]
- Anxiety [Time frame: Baseline and One month]
- Vitamin B6 status [Time frame: Baseline and One month]
Secondary outcome measures (10)
- ADHD traits [Time frame: Baseline and One month]
- Sensory processing differences [Time frame: Baseline and One month]
- Sleep quality [Time frame: Baseline and One month]
- Visual Surround Suppression of contrast perception [Time frame: Baseline and One month]
- Surround Suppression of Motion duration detection thresholds [Time frame: Baseline and One month]
- Binocular Rivalry reversal rate [Time frame: Baseline and One month]
- Binocular Rivalry suppression index [Time frame: Baseline and One month]
- Measurement of Weber Fraction for size perception [Time frame: Baseline and One month]
- Tilt illusion magnitude [Time frame: Baseline and One month]
- Ebbinghaus illusion magnitude [Time frame: Baseline and One month]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- University of Reading — Reading
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. PMID 20220012
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06234501 · UREC23/27