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

NCT03252522 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-02-08

Study results available
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Summary

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

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

COMBINATION_PRODUCT

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

60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks

DIETARY_SUPPLEMENT

Placebo

40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • University of Lethbridge

    collaborator OTHER

  • National University of Natural Medicine

    collaborator OTHER

  • Foundation for Excellence in Mental Health Care

    collaborator OTHER

  • The Waterloo Foundation

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Jeanette Johnstone · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2020-07-10
Completion
2021-05-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT03252522 on ClinicalTrials.gov