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NCT03103750 · ClinicalTrials.gov registry record · Phase 1
Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD
A Phase 1 study of ADHD, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03103750 is a Phase 1 study of ADHD that has completed, run by Yale University. The registered enrollment target is 24 participants, below the 190-participant average among 75 other ADHD trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03103750, a Phase 1 study of ADHD, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Specific Aim 1: As part of a within-subject, two-days, study design, to determine whether acute calcitriol (vs. placebo) pre-treatment is associated with greater amphetamine (Amp)-induced dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and substantia nigra / ventral tegmental area (SN/VTA) of healthy human subjects. Specific Aim 2: To determine whether acute calcitriol (vs. placebo) pre-treatment is associated with better performance on a test of attention (e.g., the Continuous Performance Task or CPT-IP), after treatment with amphetamine. Hypothesis: Investigators hypothesize that Subjects pre-treated with calcitriol will have faster reaction times/higher accuracy on the CPT-IP vs. subjects pre-treated with placebo, after treatment with amphetamine.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging (MRI)
- DRUG Placebo oral capsule
- DIETARY_SUPPLEMENT calcitriol
- DRUG PHNO
- PROCEDURE high-resolution research tomography
Study Locations (1)
Connecticut
- Connecticut Mental Health Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2023-01-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03103750
The ClinicalTrials.gov registry entry for NCT03103750 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 75 other ADHD trials with a reported enrollment target (87% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with ADHD appearing as the primary indexed condition, and to 5 interventions - of which Magnetic Resonance Imaging (MRI) is the first listed.
NCT03103750 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT03103750 about?
NCT03103750 is a clinical study titled "Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD". Specific Aim 1: As part of a within-subject, two-days, study design, to determine whether acute calcitriol (vs. placebo) pre-treatment is associated with greater amphetamine (Amp)-induced dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and substantia nigra / ventral tegmental ...
What is the current status of trial NCT03103750?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-08-15. Estimated completion is 2023-01-17.
What conditions does trial NCT03103750 study?
This clinical trial studies the following conditions: ADHD.
What interventions are being tested in trial NCT03103750?
The interventions under investigation include: Magnetic Resonance Imaging (MRI) (PROCEDURE), Placebo oral capsule (DRUG), calcitriol (DIETARY_SUPPLEMENT), PHNO (DRUG), high-resolution research tomography (PROCEDURE).
Who is sponsoring clinical trial NCT03103750?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03103750 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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