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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: Completed Phase 1 study of ADHD, sponsored by Yale University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

non-displaceable tracer binding potentials (BPND = VT - VREF / VREF), which are linearly proportional to the density of available D2/3 Rs, computed using a simplified reference tissue model (SRTM) utilizing the cerebellum as a reference region.

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

FieldValue
Enrollment Target 24 participants
Start Date 2017-08-15
Est. Completion 2023-01-17
Phase Phase 1
Yale University

1,492 total trials

What the finished NCT03103750 record still lists

NCT03103750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 190-participant average among 75 other ADHD trials with a reported enrollment target (87% lower).

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 a single indexed study location in 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.

Similar trials for ADHD

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03103750's enrollment target sits among peer trials

24 68th of 75 higher than 8 of 75 other ADHD trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other ADHD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03103750, the US trial registry maintained by the National Library of Medicine. NCT03103750 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.