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.
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.
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.
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.
Evaluating the Efficacy of Supplementation With Micronutrients for ADHD in Youth (MADDY) Study
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.
- Adverse event monitoring, assessment, and reporting in nutraceutical and phytoceutical trials for pediatric neuropsychiatric conditions: A systematic review.Journal of psychopharmacology (Oxford, England) · 2025Pooled it
- Association Between Trace Mineral Concentrations and Oxidative Stress in Children with ADHD Supplemented with Multinutrients.Biological trace element research · 2026Trial
- Kynurenine metabolites unchanged after multinutrient supplementation in children with ADHD: a secondary data analysis from the MADDY study.Journal of neural transmission (Vienna, Austria : 1996) · 2026Trial
- Multinutrient Supplementation in Children With ADHD Reduced Pro- and Anti-Inflammatory Immune Factors in the MADDY Randomized Controlled Trial.Journal of attention disorders · 2026Trial
- Patient characteristics' moderation of multinutrients treatment response in school-age children with attention deficit hyperactivity disorder.European child & adolescent psychiatry · 2026Trial
- Duration effects of micronutrients in children with ADHD: Randomised controlled trial vs. Open-Label extension.European child & adolescent psychiatry · 2026Trial
- Multinutrients Decrease Oxidative Stress in Children With ADHD: Mediation/Moderation Analysis of Randomized Controlled Trial Data.Journal of attention disorders · 2025Trial
- Gut microbiome changes with micronutrient supplementation in children with attention-deficit/hyperactivity disorder: the MADDY study.Gut microbes · 2025Trial
- Problems most concerning to parents of children with ADHD and emotional dysregulation in a randomized controlled trial of multinutrients: MADDY secondary analysis.European child & adolescent psychiatry · 2024Trial
- Evaluating mineral biomarkers as mediators and moderators of behavioural improvements in a randomised controlled trial of multinutrients for children with attention-deficit/hyperactivity disorder.The British journal of nutrition · 2024Trial
- Micronutrients for ADHD in youth (MADDY) study: comparison of results from RCT and open label extension.European child & adolescent psychiatry · 2024Trial
- Treatment response to supplemental nutrients for ADHD is independent of diet quality: the MADDY Study RCT.Nutritional neuroscience · 2024Trial
- Trial
- Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study.Current medical research and opinion · 2022Trial
- Parents' priorities and preferences for treatment of children with ADHD: Qualitative inquiry in the MADDY study.Child: care, health and development · 2022Trial
- Magnesium: Hype and Health Benefits.Current nutrition reports · 2026Review
- Review
- Article
- The Efficacy of Nutritional Interventions in Reducing Childhood/Youth Aggressive and Antisocial Behavior: A Mixed-Methods Systematic Review and Meta-Analysis.Campbell systematic reviews · 2025Review
- Investigation of a broad-spectrum micronutrient formulation as a possible precipitant of pharmacokinetic micronutrient-drug interactions.British journal of clinical pharmacology · 2025Article
Corrections and comments
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- Erratum issuedCorrection.2022
- Erratum issuedCorrection.2023
- Erratum issuedCorrection.2023
Authors and funding
14 authors at 5 institutions in 2 countries.
Funding
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
Identifiers
What OpenQuestion holds
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.