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.

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Calcitriol

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)