Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism
NCT ID: NCT06234501
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-11-08
2025-10-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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)
Pyridoxal 5'-Phosphate (100 mg)
100 mg Pyridoxal 5'-Phosphate tablet once daily with food
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.
Placebo
Placebo tablet once daily
Interventions
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Pyridoxal 5'-Phosphate (100 mg)
100 mg Pyridoxal 5'-Phosphate tablet once daily with food
Placebo
Placebo tablet once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With a diagnosis of autism
Exclusion Criteria
* Have a medical history of peripheral neuropathy
* lactose intolerance (placebo tablet is lactose based)
18 Years
60 Years
ALL
No
Sponsors
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INNOPURE
UNKNOWN
University of Reading
OTHER
Responsible Party
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David Field
Associate professor
Principal Investigators
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Dr David T Field, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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University of Reading
Reading, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David Field
Role: primary
References
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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.
Other Identifiers
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UREC23/27
Identifier Type: -
Identifier Source: org_study_id