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

## TL;DR

A study found that micronutrient treatment for ADHD in children showed lasting benefits over time, even when initially given to a placebo group.

## Contribution

The study demonstrates that the benefits of micronutrient treatment for ADHD persist over time and can catch up in children who initially received placebo.

## Key findings

- Children initially on placebo showed significant improvement in CGI-I scores during the open-label phase.
- Over half of children showed a 30% reduction in ADHD symptoms at the end of the open-label phase.
- Both groups showed significant increases in height over time with no differences in side effects.

## Abstract

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.