Clinical trial NCT04386811: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: ADHD
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Enhanced positive neurocognitive effects on the CPT-IP
timeFrame: Up to 5 hours
measure: Enhanced positive neurocognitive effects on the Spatial working memory task
timeFrame: Up to 5 hours
measure: Enhanced positive neurocognitive effects on the PRLT
timeFrame: Up to 5 hours
Secondary outcomes:
measure: Enhanced positive neurocognitive effects on the CPT-IP- hits
timeFrame: Up to 5 hours
measure: Enhanced positive neurocognitive effects on the CPT-IP- false alarms
timeFrame: Up to 5 hours
measure: Enhanced positive neurocognitive effects on the CPT-IP- random errors
timeFrame: Up to 5 hours
measure: Spatial working memory task- reaction time
timeFrame: Up to 5 hours
measure: Enhanced positive neurocognitive effects on the PRLT - win-switch / lose-stay rate
timeFrame: Up to 5 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc Potenza, MD
role: PRINCIPAL_INVESTIGATOR
References: