ArticleContemporary clinical trials communications2019
Rationale and design of an international randomized placebo-controlled trial of a 36-ingredient micronutrient supplement for children with ADHD and irritable mood: The Micronutrients for ADHD in Youth (MADDY) study.
Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 20 papers.
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
20 citing papers in PubMed, 26 citations in OpenAlex.
- 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
- Gut microbiome changes with micronutrient supplementation in children with attention-deficit/hyperactivity disorder: the MADDY study.Gut microbes · 2025Trial
- Multinutrients Decrease Oxidative Stress in Children With ADHD: Mediation/Moderation Analysis of Randomized Controlled Trial Data.Journal of attention disorders · 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
- 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
- Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial.Journal of the American Academy of Child and Adolescent Psychiatry · 2022Trial
- Urinary Histamine Not Associated with Severity of Symptoms of ADHD and Emotional Dysregulation: A Cross-sectional Secondary Data Analysis from the Micronutrients for ADHD in Youth (MADDY) Study.Advances in neurodevelopmental disorders · 2024Article
- Dr. Johnstone et al. Reply to Dr. Hamilton.Journal of the American Academy of Child and Adolescent Psychiatry · 2023Article
- Dr. Johnstone et al. Reply to Dr. Elmrayed.Journal of the American Academy of Child and Adolescent Psychiatry · 2023Article
- Fruit and vegetable intake is inversely associated with severity of inattention in a pediatric population with ADHD symptoms: the MADDY Study.Nutritional neuroscience · 2023Article
- Pain sensitivity and perceptual sensitivity are associated with severity of emotional dysregulation in children with ADHD: a cross-sectional analysis using the Temperament in Middle Childhood Questionnaire.Disability and rehabilitation · 2023Article
- Article
- Development of a Composite Primary Outcome Score for Children with Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation.Journal of child and adolescent psychopharmacology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundAttention-Deficit/Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental disorder affecting up to 9% of children and substantial numbers of adults. Existing pharmacologic treatments often improve symptoms, but concerns exist over side effects, stigma, potential long-term health effects, and residual irritability, often treated with adjunctive antipsychotics. To address public and clinician demand for non-pharmacologic evidence-based treatments, this study will examine efficacy of a 36-ingredient micronutrient (vitamin/mineral) supplement as treatment for children with ADHD and irritability.
methodsAn international team of experts in ADHD, mood dysregulation, nutrition, epidemiology, and clinical trials conferred to develop/refine a protocol powered to detect a medium effect. The study will employ a fully-blind randomized controlled trial (RCT) design, comparing the micronutrient supplement to matched placebo in 135 children aged 6-12 with ADHD symptoms and irritability, based on the parent-rated Child and Adolescent Symptom Inventory-5 (CASI-5). Irritability will be measured by at least one symptom of oppositional defiant disorder (ODD) or disruptive mood dysregulation disorder (DMDD). Based on research suggesting an irritable ADHD subtype, the primary outcome will be a composite score comprised of the CASI-5 subscales: ADHD, ODD, DMDD, and the Peer Conflict Scale, which assesses anger and aggression perpetrated towards peers. Participants will provide biological samples (blood, urine, saliva, hair and stool) to explore the micronutrients' mechanisms of action. DISCUSSION: This study is the first adequately powered RCT in North America to examine both behavioral responses to, and biological mechanisms of, micronutrients for ADHD and irritability in children. If found efficacious, broad-spectrum micronutrients, given at therapeutic doses, may provide an evidence-based alternative to prescription medications for ADHD and associated irritability.
trial registrationNCT03252522. Registered 26 July 2017.
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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.