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 early · Phase 1 · Has a placebo group

Conditions studied: ADHD

In brief

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

Key facts

Study ID

NCT04386811

Run by

Yale University

People needed

3

Starts

2020-08-05

Expected to finish

2020-09-29

Last updated by the study team

2024-02-07

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• CMHC — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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