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

Attention-Deficit/Hyperactivity Disorder (ADHD), a chronic neurodevelopmental disease, is treatable using pharmacological interventions, albeit at the cost of substantial side effects, social stigma, chronic negative impacts on health, and symptoms of irritability requiring additional antipsychotics. This has led both the public and healthcare professionals to request effective, evidence-based non-pharmacological treatment alternatives. In a fully-blind randomized controlled trial (RCT) by Johnstone et al. (2019), the authors investigated the impact of a 36-ingredient micronutrient (vitamin/mineral) supplement on ADHD and irritability symptoms, diagnosed as per the parent-rated Child and Adolescent Symptom Inventory-5 (CASI-5) and the presence of at least one symptom of oppositional defiant disorder (ODD) or disruptive mood dysregulation disorder (DMDD), in a sample of 135 children (aged between 6-12 years). The children were scored based on a combination of CASI-5 subscales (ADHD, ODD, DMDD) and the Peer Conflict Scale (which evaluates anger and aggression directed at peers). In addition, samples of blood, urine, saliva, hair and stool were collected. The authors comment that their study is the first appropriate RCT in North America to investigate the mechanism of action and behavioral impact of micronutrient supplements on ADHD and irritability in children. Based on the results, therapeutic doses of broad-spectrum micronutrients may present an evidence-based, non-pharmacological treatment alternative for ADHD and irritability. [NPID: ADHD, irritability, micronutrients, minerals, vitamins]

Year: 2019

Reference: Johnstone, J. M., Leung, B., Gracious, B., Perez, L., Tost, G., Savoy, A., Hatsu, I., Hughes, A., Bruton, A., & Arnold, L. E. (2019). 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. Contemporary clinical trials communications, 16, 100478. https://doi.org/10.1016/j.conctc.2019.100478