Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Enhanced positive neurocognitive effects on the CPT-IP
研究概览
简要总结
The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD.
详细描述
The specific aim of this study is to determine whether acute calcitriol (vitaminD) administration (compared to placebo) enhances the neurocognitive effects of of current stimulant medications as measured by tasks of vigilance/attention, spatial working memory, and reversal learning in individuals with (attention deficit hyperactivity disorder (ADHD) using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
Primary Hypothesis: It is hypothesized that calcitriol (versus placebo) administration will enhance positive neurocognitive effects of current stimulant medications in individuals with ADHD.
Secondary (Exploratory) Hypothesis: It is hypothesized that calcitriol (versus placebo) administration alone will also enhance neurocognitive performance on tasks of attention/vigilance and/or spatial working memory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •Voluntary, written, informed consent
- •Physically healthy by medical and psychiatric history
- •DSM-5 diagnosis of ADHD
- •Point of Care Test results for Vitamin D equal or higher than 20 ng/ml
- •English speaking
排除标准
- •Medical contraindication to calcitriol administration (e.g., history of hypersensitivity to calcitriol or any component of the formulation, hypercalcemia or vitamin D toxicity)
- •History of substance dependence (e.g., alcohol, opiates, sedative hypnotics), except for nicotine
- •A primary major DSM-V psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-V (SCID), except ADHD
- •A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness
- •Current use of psychotropic and/or potentially psychoactive prescription medications, except prescribed stimulants
- •Use of any prescription medications and/or over-the-counter medications, vitamins (including vitamin D) and/or herbal supplements which could have a negative clinical interaction with calcitriol or which could confound scientific results of the study, within 2 weeks prior to each test day (e.g., thiazide diuretics, Mg based antiacids, digoxin, etc,).
- •Levels of 25(OH)D3 below 20 ng/ml .
- •History of kidney stones within the past 5 years
- •History of renal failure
- •History of parathyroid disorder (hyper or hypoparathyroidism)
- •History of osteoporosis or any pathologic fractures
- •Vitamin D supplementation in any form in the past 3 months
- •Known hypersensitivity to calcitriol
- •Malabsorption syndromes (i.e. Celiac sprue)
研究组 & 干预措施
Calcitriol
干预措施: Calcitriol (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Enhanced positive neurocognitive effects on the CPT-IP
时间窗: Up to 5 hours
On the Continuous Performance Task (CPT-IP) subjects are shown a random sequence of different numbers and are instructed to press a button as quickly and accurately as possible upon detection of two identical pairs of numbers, and to withhold their response to any other sequence of letters. Outcomes will be measured by d prime.
Enhanced positive neurocognitive effects on the Spatial working memory task
时间窗: Up to 5 hours
The spatial working memory task is a measure of working memory. As part of the task, stimuli will be projected onto the computer screen and target stimuli can be spatial locations, different visual stimuli, sound or text. Outcomes will be measured by percent correct.
Enhanced positive neurocognitive effects on the PRLT
时间窗: Up to 5 hours
The Probabilistic Reversal Learning Task (PRLT) measures subjects' perseverative responding in the context of changing reward contingencies / cues. Outcomes will be measured by numbers of reversal achieved, total points, and error types.
次要结局
- Enhanced positive neurocognitive effects on the CPT-IP- hits(Up to 5 hours)
- Spatial working memory task- reaction time(Up to 5 hours)
- Enhanced positive neurocognitive effects on the PRLT - win-switch / lose-stay rate(Up to 5 hours)
- Enhanced positive neurocognitive effects on the CPT-IP- random errors(Up to 5 hours)
- Enhanced positive neurocognitive effects on the CPT-IP- false alarms(Up to 5 hours)