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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234501
• Other study ID #: UREC23/27
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: University of Reading
• Contact: Dr David T Field, PhD
• Phone: +441183785004
• Email: d.t.field[@]reading.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Dietary Supplement:
• Pyridoxal 5'-Phosphate (100 mg)
100 mg Pyridoxal 5'-Phosphate tablet once daily with food

Other:
• Placebo
Placebo tablet once daily

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	INNOPURE

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. Erratum In: J Neurosci. 2013 Jun 19;33(25):10583. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory hyperreactivity	Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D.	Baseline and One month
Primary	Sensory hyperreactivity	Sensory hyperreactivity will be measured by a subscale of the Comprehensive Autistic Trait Inventory (CATI).	Baseline and One month
Primary	Anxiety	Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire.	Baseline and One month
Primary	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	ADHD traits	Adult Attention Deficit Hyperreactivity Disorder Self-Report Scale (ASRS-v1.1)	Baseline and One month
Secondary	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.	Baseline and One month
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Baseline and One month
Secondary	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).	Baseline and One month
Secondary	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).	Baseline and One month
Secondary	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).	Baseline and One month
Secondary	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).	Baseline and One month
Secondary	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.	Baseline and One month
Secondary	Tilt illusion magnitude	Magnitude of the tilt illusion is a correlate of GABA concentration in the occipital cortex (Song et al., 2017).	Baseline and One month
Secondary	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)	Baseline and One month