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

University of Reading

Status: Not yet enrolling

Conditions: Autism

Treatments: Other: Placebo; Dietary Supplement: Pyridoxal 5'-Phosphate (100 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT06234501

UREC23/27

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Vitamin-B6

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Pyridoxal 5'-Phosphate (100 mg)

Placebo

Placebo Comparator group

Description:

Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month.

Treatment:

Other: Placebo