CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 135 enrolled
Drug / intervention
Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03252522
NCT03252522Phase 2Completed
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Evaluating the Efficacy of Supplementation With Micronutrients for ADHD in Youth (MADDY) Study

Oregon Health and Science University·interventional·Posted Aug 17, 2017·Updated Feb 8, 2023

In Brief

A Phase 2 clinical trial evaluating Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 135 participants across 3 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesCanada, United States
CollaboratorsOhio State University, University of Lethbridge, National University of Natural Medicine, Foundation for Excellence in Mental Health Care, The Waterloo Foundation

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 17, 2017
Enrollment StartApr 23, 2018
Primary CompletionJul 10, 2020
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.9 years ago

Interventions

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

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

Placebodietary

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