7.1 RANDOMIZED CONTROLLED TRIAL OF MULTINUTRIENTS FOR ADHD WITH EMOTIONAL DYSREGULATION

Abstract

This session aims to examine the efficacy of broad-spectrum multinutrients for ADHD and emotional dysregulation. In the Micronutrients for ADHD in Youth (MADDY) randomized controlled trial, unmedicated children (N = 135) aged 6-12 years with ADHD and emotional dysregulation (based on parent reports) at 3 sites (Oregon, Ohio, Canada) were randomized to a 36-ingredient multinutrient supplement (vitamins + minerals) or placebo (3:2 ratio) for 8 weeks. The primary outcomes were the clinician-rated Clinical Global Impression–Improvement (CGI-I; 1 or 2 = responder), and the parent-rated Child and Adolescent Symptom Inventory-5 (CASI-5) composite score comprised of ADHD, ODD, DMDD, and peer-conflict symptoms, including impairment scores for each. A teacher also completed the CASI-5. With a mean age of 9.8 years, 93% (N = 126) of the 135 randomized children comprised the intention-to-treat population. Participants’ demographic and baseline clinical characteristics were well matched between treatment groups, with no significant differences (all p > 0.05). On the CGI-I, 54% of those assigned micronutrients vs 18% of the placebo group were responders (Cramér’s V = 0.37; p < 0.001). However, parent-rated CASI-5 composite scores did not differ between groups (p = 0.70); both improved from baseline (p < 0.01). Teacher reports showed significant between-group difference favoring micronutrients on the Peer Conflict subscale, which was 0.13 points lower for micronutrients (95% CI, –0.26 to –0.01, p = 0.04; Cohen’s d = 0.16). The micronutrient group grew 6 mm more than the placebo group (p = 0.002; Cohen’s d = 1.15). Blinding was maintained. Micronutrients showed global improvement over placebo by blinded clinician rating and teacher reports of peer conflict, but not by parent report on the CASI-5 in children with ADHD and irritability. The micronutrient group showed greater height growth velocity. Micronutrients were well tolerated, and the majority of children adhered to the treatment. This randomized controlled trial replicates the efficacy reported for ADHD in 2 smaller RCTs of a similar formula, containing all vitamins and known essential minerals in therapeutic amounts between the Recommended Dietary Allowance and Tolerable Upper Intake Level.