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