Duration Effects of Micronutrients in Children with ADHD: Randomised Controlled Trial vs Open-Label Extension

ADHD in Children

ADHD is a common mental disorder affecting children [1]. If left untreated, it increases the risk of anti-social behaviours, poor life quality, substance abuse, and worse academic outcomes [2-4].

Medications are the common treatment for ADHD, but their long-term efficacy is not well documented, and linked with negative side effects like sleep issues, slowed growth velocity and loss of appetite [5-7].

Do Micronutrients Work?

The commonly used micronutrient formula in research is Daily Essential Nutrients (DEN), which contains a range of vitamins, minerals and amino acids, at a dose that is likely to help people without eliciting side effects in the majority of the population [8].

Evidence suggests that more children with ADHD respond to treatment when taking micronutrients (47 – 54%) compared to placebo groups (18 – 28%), with significant benefits observed in inattentive symptoms. The benefits also extend to improvements in aggression and mood swings [8, 9]. Interestingly, longer exposure to micronutrients shows continual improvement in ADHD symptoms [10].

The Current Study

Initially, 93 children participated in a ten-week trial, where half were randomly allocated to take micronutrients and some to placebo (pills that mimicked micronutrient capsules). This was the randomisation phase (RCT). After 10 weeks, participants had the option to continue on the trial for an additional 10 weeks, during which everyone received micronutrients (open label phase). Our study followed 78 children who stayed on for 20 weeks.

We named the groups:

• Micronutrient-Micronutrient group (M-M): Children who had micronutrients for 20 weeks.
• Placebo-Micronutrient group (P-M): Children who were initially on placebo and switched to micronutrients for 10 weeks.

The children’s ADHD and mood dysregulation symptoms, as well as overall functioning, were measured at baseline (start of trial), week 10 (end of RCT), and week 20 (end of open label).

What did we find?

1. Symptoms improved over time. Compared to Week 10 (29.7% in M-M and 16.2% in P-M), children in both groups saw a significant increase in the number of treatment responders at Week 20 (61% in M-M and 45.9% in P-M), for ADHD symptoms, based on a 30% decrease in scores based on clinician ratings.
2. Those who switched caught up. Children who started on the placebo improved quickly when they began micronutrients, narrowing the gap with the M-M group.
3. Better emotional control. Both groups showed better moods, fewer instances of emotional dysregulation, and improved overall functioning by the end of the study.
4. Good safety profile. No group differences were found in side effects. Most side effects resolved on their own, and others simply needed a dose adjustment.

Takeaway

Twenty weeks of micronutrient supplementation could support maintenance and continual improvement of ADHD symptoms. The study supports micronutrients as an alternative treatment for ADHD, especially considering their safety profile. More research is needed to test longer duration effects in more naturalistic settings.