RecruitingNAINTERVENTIONAL

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

This study is investigating if a daily 100mg vitamin B6 supplement can help autistic adults who experience strong reactions to everyday sights, sounds, or touches, and who also deal with anxiety. Researchers want to see if the vitamin can make a difference compared to taking a placebo, which is a pill with no active medicine. They're also planning to look at how vitamin B6 might affect sleep, attention issues, and how people see and process visual information. The main goal is to find out if this vitamin could be a helpful option for managing some of the challenges faced by autistic individuals.

At a glance

Status

Recruiting

Phase

Sponsor

University of Reading

Enrolment target

Start

08 Nov 2024

Estimated completion

01 Jul 2026

Autism

What is this study about?

This research study is trying to understand if taking a specific dose of vitamin B6 every day could help autistic adults. Specifically, it's looking at two main things: whether the vitamin can lessen very strong reactions to sensory experiences (like being overwhelmed by bright lights or loud noises), and if it can help reduce feelings of anxiety or worry.

To do this, some people in the study will take 100mg of vitamin B6 daily, while others will take a 'placebo'. A placebo looks just like the real vitamin pill but doesn't contain any active ingredient. This helps the researchers know for sure if any changes seen are due to the vitamin itself, rather than just the expectation of feeling better.

Beyond sensory reactions and anxiety, the study will also explore other areas. They're keen to see if vitamin B6 might have an impact on sleep quality, symptoms linked to Attention Deficit Hyperactivity Disorder (ADHD), and how people process what they see. These extra checks could give us a broader understanding of how vitamin B6 might affect different aspects of life for autistic individuals.

Key takeaways

The study tests vitamin B6 for sensory reactions and anxiety in autistic adults.
Participants will take either vitamin B6 or a dummy pill (placebo).
It also looks at effects on sleep, ADHD symptoms, and visual processing.
You must be an autistic adult, aged 18-60, to be eligible.
Cannot join if taking high-dose B6, certain medicines, have nerve damage, or lactose intolerance.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 60 years old and have a diagnosis of autism. The researchers are looking for people who fit these basic requirements.

There are also some reasons why you might not be able to take part. For example, if you're already taking another supplement that has more than 2mg of vitamin B6 in it, or if you're taking certain medicines called GABA agonist drugs, you wouldn't be able to join. This is to make sure the study results are clear and not affected by other substances.

Also, if you have a medical condition called peripheral neuropathy (a type of nerve damage), or if you can't digest lactose (milk sugar), you wouldn't be able to participate. This is because the dummy pill used in the study contains lactose.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Do you have a formal diagnosis of autism?
Are you NOT currently taking a vitamin B6 supplement with more than 2mg B6?
Are you NOT taking certain medications called GABA agonist drugs?
Do you NOT have a medical history of peripheral neuropathy (nerve damage)?
Do you NOT have lactose intolerance?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would either receive a daily 100mg vitamin B6 supplement or a daily 'placebo' pill (a dummy pill with no active ingredient). You wouldn't know which one you're taking. You would be expected to attend some appointments for assessments, which might involve answering questionnaires about your anxiety, sensory experiences, sleep, and attention. You might also complete some visual tasks on a computer. The total duration of your participation, including how many visits and follow-ups are needed, would be fully explained before you agree to join.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but the information gained could help others in the future by understanding if vitamin B6 is helpful for autistic individuals. All medicines have potential side effects, and while vitamin B6 is generally safe at this dose, any risks or discomforts will be fully explained before you agree to join. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Reading
Verified postcode
Reading, United Kingdom· Recruiting

Common questions

What is a 'placebo'?

A placebo is a pill that looks exactly like the real vitamin B6 pill but doesn't contain any active medicine. It helps researchers compare if the vitamin is truly making a difference.

Will I know if I'm getting vitamin B6 or the placebo?

No, you won't know whether you're taking the active vitamin B6 or the placebo. This is standard practice in research to make the results as fair and accurate as possible.

What happens if I already take a vitamin B6 supplement?

If your current supplement contains more than 2mg of vitamin B6, you unfortunately wouldn't be able to join this particular study. The researchers need to control the B6 intake carefully.

What does 'sensory hyperreactivity' mean?

It means having very strong or overwhelming reactions to everyday things like bright lights, loud noises, certain textures, or strong smells that others might not notice as much.

How long will the study last?

The exact length of the study for each participant, including the number of visits, will be clearly explained to you before you agree to take part.

How to find out more

Dr David T Field, PhD

d.t.field@reading.ac.uk +441183785004 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.