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.

NCT04386811 | Terminated Phase 1

• 1 other identifier: 2000028035
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• Enhanced positive neurocognitive effects on the CPT-IP

  On the Continuous Performance Task (CPT-IP) subjects are shown a random sequence of different numbers and are instructed to press a button as quickly and accurately as possible upon detection of two identical pairs of numbers, and to withhold their response to any other sequence of letters. Outcomes will be measured by d prime.

  Up to 5 hours

• Enhanced positive neurocognitive effects on the Spatial working memory task

  The spatial working memory task is a measure of working memory. As part of the task, stimuli will be projected onto the computer screen and target stimuli can be spatial locations, different visual stimuli, sound or text. Outcomes will be measured by percent correct.

  Up to 5 hours

• Enhanced positive neurocognitive effects on the PRLT

  The Probabilistic Reversal Learning Task (PRLT) measures subjects' perseverative responding in the context of changing reward contingencies / cues. Outcomes will be measured by numbers of reversal achieved, total points, and error types.

  Up to 5 hours

Secondary Outcomes (5)

• Enhanced positive neurocognitive effects on the CPT-IP- hits

  Up to 5 hours

• Enhanced positive neurocognitive effects on the CPT-IP- false alarms

  Up to 5 hours

• Enhanced positive neurocognitive effects on the CPT-IP- random errors

  Up to 5 hours

• Spatial working memory task- reaction time

  Up to 5 hours

• Enhanced positive neurocognitive effects on the PRLT - win-switch / lose-stay rate

  Up to 5 hours

Study Arms (2)

Calcitriol

EXPERIMENTAL

Drug: Calcitriol

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Calcitriol DRUG

A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design.

Calcitriol

Placebo OTHER

A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

CMHC

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Marc Potenza, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 13, 2020
• Study Start: August 5, 2020
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (1)