Health TrialsbyHealthPanel

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

ConditionAutism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Reading

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 18 to 60

With a diagnosis of autism

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pyridoxal 5'-Phosphate (100 mg)

    Dietary supplement

    100 mg Pyridoxal 5'-Phosphate tablet once daily with food

  • Placebo

    Other intervention

    Placebo tablet once daily

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Vitamin-B6Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sensory hyperreactivity

Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D.

Time frame
Baseline and One month
2

Sensory hyperreactivity

Sensory hyperreactivity will be measured by a subscale of the Comprehensive Autistic Trait Inventory (CATI).

Time frame
Baseline and One month
3

Anxiety

Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire.

Time frame
Baseline and One month
4

Vitamin B6 status

The concentration of different forms of Vitamin B6 in blood plasma will be measured (Pyridoxal-5'-phosphate, pyridoxine, pyridoxal, pyridoxamine)

Time frame
Baseline and One month

Secondary outcomes

1

ADHD traits

Adult Attention Deficit Hyperreactivity Disorder Self-Report Scale (ASRS-v1.1)

Time frame
Baseline and One month
2

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.

Time frame
Baseline and One month
3

Sleep quality

Pittsburgh Sleep Quality Index (PSQI)

Time frame
Baseline and One month
4

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).

Time frame
Baseline and One month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Reading

Lead sponsor

INNOPURE

Collaborator

Source ClinicalTrials.gov
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