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NCT03252522 · ClinicalTrials.gov registry record · Phase 1

Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study

A Phase 1 study, sponsored by Oregon Health and Science University.

Completed
Registry status
Phase 1
Development phase
135
Enrollment target

NCT03252522: Completed Phase 1 study, sponsored by Oregon Health and Science University.

NCT03252522 is a Phase 1 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 135 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03252522, a Phase 1 study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
Phase 1
Development phase
135 participants
Enrollment target

Study Summary

This proposed research will use randomized control trial (RCT) methodology and compare micronutrients with placebo in 135 children with ADHD.

Primary Outcome

Primary outcome measure, defined a priori, reflecting the often-comorbid ADHD symptoms of emotional dysregulation irritable mood, anger or aggression), are the parent-rated Child and Adolescent Symptom Inventory (CASI-5). The CASI-5 is based on the DSM-5 symptom criteria. The subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict that will be combined into a total composite score; range is 0-3 (never, sometimes, often, very often).

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • COMBINATION_PRODUCT Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2018-04-23
Est. Completion 2021-05-31
Phase Phase 1

What the finished NCT03252522 record still lists

NCT03252522 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03252522 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03252522 about?

NCT03252522 is a clinical study titled "Micronutrients for Attention-Deficit Hyperactivity Disorder in Youth (MADDY) Study". This proposed research will use randomized control trial (RCT) methodology and compare micronutrients with placebo in 135 children with ADHD.

What is the current status of trial NCT03252522?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2018-04-23. Estimated completion is 2021-05-31.

What interventions are being tested in trial NCT03252522?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT03252522?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03252522's enrollment target sits among peer trials

135 425th of 2000 higher than 1,574 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT03252522, the US trial registry maintained by the National Library of Medicine. NCT03252522 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.