Status:
TERMINATED
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.
Lead Sponsor:
Yale University
Conditions:
ADHD
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 measu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04386811
Start Date
August 5 2020
End Date
September 29 2020
Last Update
February 7 2024
Active Locations (1)
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1
CMHC
New Haven, Connecticut, United States, 06519