Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-he… (NCT04386811) | Clinical Trial Compass
TerminatedPhase 1
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.
Stopped: Following Yale University resuming in-person research activities, the investigators no longer had dedicated funding for the study and were unable to secure additional funding to meet the research goals.
United States3 participantsStarted 2020-08-05
Plain-language summary
The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD.
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
What they're measuring
1
Enhanced positive neurocognitive effects on the CPT-IP
Timeframe: Up to 5 hours
2
Enhanced positive neurocognitive effects on the Spatial working memory task
Timeframe: Up to 5 hours
3
Enhanced positive neurocognitive effects on the PRLT