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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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-02-07

No results posted yet for this study

Summary

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

Conditions

  • ADHD

Interventions

DRUG

Calcitriol

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Marc Potenza, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2020-09-29
Completion
2020-09-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04386811 on ClinicalTrials.gov