Duration effects of micronutrients in children with ADHD: Randomised controlled trial vs. Open-Label extension.

A 10-week randomised controlled trial (RCT) showed efficacy of micronutrients in improving symptoms associated with Attention-Deficit/Hyperactivity Disorder (ADHD). This study investigated duration effects of micronutrient treatment through the open label (OL) phase and document the micronutrient effect on those initially allocated to placebo. Children aged 7-12 years randomized to micronutrients or placebo for 10 weeks (RCT), then received 10 weeks OL, creating two groups: placebo first then micronutrients (P-M) or micronutrients in both phases (M-M). Assessments included measures of ADHD, emotional dysregulation and Clinical-Global-Impression-Improvement (CGI-I). Of the 93 children enrolled in RCT, 78 (83.9%) completed OL; 37 in P-M and 41 in M-M. For those initially assigned to placebo, CGI-I responders significantly increased from 32.4% in the RCT to 64.9% in OL (p = .002); those who took micronutrients for 20 weeks increased from 46.3% (end-of-RCT) to 63.4% responders (end-of-OL) but this was not significant (p = .065). Over half of children were treatment responders at end-of-OL, based on 30% reduction in ADHD symptoms from baseline, both from parent (61.5%) and clinician (53.8%) report. Pre-post effect sizes within both groups were significant and very large for all measures, with no significant group differences at end of OL. There were no differences in side effects. Both groups showed significant increases in height over time. This study supports micronutrients as a viable treatment option for ADHD with acute changes maintained and improved over a further 10-week period, with the placebo group catching up to those exposed to micronutrients for full trial duration.