Evidence map›Paper›PMID 34303786›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2022

Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial.

Jeanette M Johnstone, Irene Hatsu, Gabriella Tost, Priya Srikanth, Leanna P Eiterman, Alisha M Bruton, Hayleigh K Ast, Lisa M Robinette, Madeline M Stern, Elizabeth G Millington and 4 more

Erratum issued Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03252522 (Evaluating the Efficacy of Supplementation With Micronutrients for ADHD in Youth), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03252522 phase1 / phase2completednot on this map

Evaluating the Efficacy of Supplementation With Micronutrients for ADHD in Youth (MADDY) Study

TypeinterventionalSponsorOregon Health and Science UniversityRan2018 to 2021Enrolled135ConditionsAttention Deficit Hyperactivity DisorderArmsBroad Spectrum Micronutrients, a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

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  16. Magnesium: Hype and Health Benefits.Current nutrition reports · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Jeanette M JohnstoneOregon Health & Science University, Portland; National University of Natural Medicine, Helfgott Research Institute, Portland, Oregon. Electronic address: jojeanet@ohsu.edu.
Irene HatsuThe Ohio State University, Columbus.
Gabriella TostOregon Health & Science University, Portland.
Priya SrikanthOHSU-Portland State University School of Public Health, Oregon.
Leanna P EitermanThe Ohio State University, Columbus.
Alisha M BrutonOregon Health & Science University, Portland.
Hayleigh K AstOregon Health & Science University, Portland.
Lisa M RobinetteThe Ohio State University, Columbus.
Madeline M SternThe Ohio State University, Columbus.
Elizabeth G MillingtonUniversity of Lethbridge, Alberta, Canada.
Barbara L GraciousThe Ohio State University, Columbus; Orange Park Medical Center, Florida, and the Edward Via College of Osteopathic Medicine, Spartanburg, South Carolina.
Andrew J HughesOregon Health & Science University, Portland.
Brenda M Y LeungUniversity of Lethbridge, Alberta, Canada.
L Eugene ArnoldThe Ohio State University, Columbus.
The Ohio State University · USOregon Health & Science University · USUniversity of Lethbridge · CANational University of Natural Medicine · USPortland State University · US

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
Oregon Clinical and Translational Research InstituteUL1TR000128 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI ELLISON, DAVID H · 2012 to 2015
$28.7M
The Ohio State University Center for Clinical and Translational Science (UL1)UL1TR000090 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2012 to 2013
$7.9M
CAM Research Training in Neuroscience &StressT32AT002688 · NCCIH · OREGON HEALTH & SCIENCE UNIVERSITY · PI OKEN, BARRY S, SOUMYANATH, AMALA · 2005 to 2025
$7.2M
Building Research across Interdisciplinary Gaps (BRIDG) R90 Training Program - Administrative SupplementR90AT008924 · NCCIH · NATIONAL UNIVERSITY OF NATURAL MEDICINE · PI BRADLEY, RYAN D, ZWICKEY, HEATHER LEA · 2015 to 2025
$5.2M
Mentorship in Clinical Complementary and Integrative Health ResearchK24AT011568 · NCCIH · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BRADLEY, RYAN D · 2021 to 2025
$762k
NCATS NIH HHS UL1 TR000090NCATS NIH HHS UL1 TR000128NCATS NIH HHS UL1 TR002369NCCIH NIH HHS K24 AT011568NCCIH NIH HHS R90 AT008924NCCIH NIH HHS T32 AT002688
6 · The paper itself

Abstract

objectiveTo evaluate whether micronutrients (vitamins/minerals) benefit attention-deficit/hyperactivity disorder (ADHD) and irritability in a North American pediatric sample.

methodA 3-site, 8-week, placebo-controlled, randomized clinical trial of micronutrients was conducted in nonmedicated children aged 6 to 12 years with ADHD and at least 1 impairing irritability symptom by parent report on the Child and Adolescent Symptom Inventory-5 (CASI-5). A priori-defined primary outcomes were Clinical Global Impression-Improvement (CGI-I) (CGI-I of 1 or 2 = treatment responder) and parent-rated CASI-5 composite score of ADHD, oppositional defiant, disruptive mood dysregulation, and peer conflict symptoms, including impairment scores.

resultsOf 135 randomized (mean age 9.8 years), 126 youths (93%) comprised the modified intention-to-treat population. Blinding was maintained. For the CGI-I, 54% of the micronutrient and 18% of the placebo group were responders (risk ratio = 2.97, 97.5% CI = 1.50, 5.90, p < .001). CASI-5 composite scores improved significantly for both groups (p < .01), with a mean change of -0.31 (95% CI = -0.39, -0.23) in the micronutrient group and a mean change of -0.28 (95% CI = -0.38, -0.19) in the placebo group. However, the between-group difference was not significant (mean change = -0.02; 97.5% CI = -0.16, 0.12, effect size = 0.07, p = .70). The micronutrient group grew 6 mm more than the placebo group (p = .002). No serious adverse events or clinically significant changes from baseline in blood and urine tests occurred.

conclusionMicronutrients showed global benefit over placebo by blinded clinician rating, but not by parent-report CASI-5 composite rating in a population with ADHD and irritability. Micronutrients showed greater height growth. Micronutrients were well tolerated, and the majority of participants adhered to the number of capsules prescribed. This randomized controlled trial replicates safety and efficacy reported for ADHD in 2 smaller trials of a similar formula containing all vitamins and known essential minerals in amounts between the Recommended Dietary Allowance and Upper Tolerable Intake Level. CLINICAL TRIAL REGISTRATION INFORMATION: Micronutrients for ADHD in Youth (MADDY) Study; https://clinicaltrials.gov; NCT03252522.

Indexed as

Attention Deficit Disorder with HyperactivityAdolescentAffectChildDouble-Blind MethodHumansMicronutrientsMineralsTreatment OutcomeVitaminsMicronutrientsMineralsVitaminsattention-deficit/hyperactivity disorderdysregulated moodirritabilitymicronutrients

Identifiers

PMID34303786
PMCPMC8782920
OpenAlexW3184322179

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.