Testing the Potential of High-dose Vitamin B6 Supplements for Sensory Reactivity in Autism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 to 60
- •With a diagnosis of autism
排除标准
- •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)
研究组 & 干预措施
Vitamin-B6
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)
干预措施: Pyridoxal 5'-Phosphate (100 mg) (Dietary Supplement)
Placebo
Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month.
干预措施: Placebo (Other)
结局指标
主要结局
Anxiety
时间窗: Baseline and One month
Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire.
Vitamin B6 status
时间窗: Baseline and One month
The concentration of different forms of Vitamin B6 in blood plasma will be measured (Pyridoxal-5'-phosphate, pyridoxine, pyridoxal, pyridoxamine)
Sensory hyperreactivity
时间窗: Baseline and One month
Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D.
次要结局
- ADHD traits(Baseline and One month)
- Visual Surround Suppression of contrast perception(Baseline and One month)
- Surround Suppression of Motion duration detection thresholds(Baseline and One month)
- Measurement of Weber Fraction for size perception(Baseline and One month)
- Sensory processing differences(Baseline and One month)
- Sleep quality(Baseline and One month)
- Binocular Rivalry reversal rate(Baseline and One month)
- Tilt illusion magnitude(Baseline and One month)
- Ebbinghaus illusion magnitude(Baseline and One month)
- Binocular Rivalry suppression index(Baseline and One month)
研究者
David Field
Associate professor
University of Reading