Summary: Children with ADHD and emotional regulation disorders who consumed a micronutrient formal made of essential minerals and vitamins were three times more likely to show improvements in symptoms compared to those who did not consume the formula.
Source: Elsevier
A study in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) reports children with ADHD and emotional regulation randomized to take a micronutrient formula were three times more likely to show symptomatic improvement on blinded clinician ratings, compared to those in the placebo group (54% versus 18%).
The micronutrient formula, consisting of all known vitamins and essential minerals, was administered for eight weeks.
“Supplementing with all known vitamins and essential minerals, at doses between Recommended Daily Allowance and Upper Tolerable Limit, may improve mood and concentration in children with ADHD and emotional dysregulation,” said lead author Jeanette Johnstone, PhD, Assistant Professor, Department of Child and Adolescent Psychiatry, Oregon Health & Science University and Helfgott Research Institute, National University of Natural Medicine.
“These findings, replicating results of a previous randomized trial of micronutrients in children with ADHD conducted in New Zealand, confirm that supplementation with a broad range of nutrients may benefit some children. These findings may offer guidance to doctors and families seeking integrative treatments for their children with ADHD and related emotional dysregulation,” Dr. Johnstone noted.
The triple-blinded study enrolled 135 medication-free children and their parents at three sites (Portland, Oregon; Columbus, Ohio; Alberta, Canada) and randomized participants to either micronutrient or placebo capsules for eight weeks. Three-quarters of the participants were adherent to the study protocol.
The intervention was well-tolerated, with no significant differences in adverse events between the micronutrient and placebo groups, or safety concerns based on blood and urine tests.
Parents, children and clinicians were blinded to treatment allocation and were not able to guess assignment better than chance.
In addition to behavioral and emotional benefits, children taking micronutrients grew 6mm more in height than those taking placebo after adjusting for baseline height.
“The growth finding, also a replication from the previous child micronutrient study, is particularly encouraging, as height suppression is a concern with first-line ADHD medication,” Dr. Johnstone added.
In contrast to clinician ratings, parents, who were also blinded to their child’s treatment allocation, reported significantly improved behavior that was equal in both the micronutrient and placebo groups, with no significant between-group differences, highlighting the importance of blinded clinician ratings.
“No treatment is 100% effective for all with ADHD,” commented L. Eugene Arnold, MD, Professor Emeritus of Psychiatry & Behavioral Health at Ohio State University and one of the senior co-authors.
“For example, about 2/3 respond to the first stimulant drug tried, which is an established first-line ADHD treatment despite emotional, appetite, and growth side effects. So, it’s encouraging that a good half of the children responded to this relatively safe treatment.”
“Future studies will focus on the micronutrients’ mechanisms of action and subgroup responses to understand for whom and why this intervention works. Mechanistic hypotheses to be tested include changes in the gut microbiome and its metabolome, reductions in inflammatory markers (e.g. cytokines), replenishment of minerals, and optimization of neurotransmission.
“In order to increase parent sensitivity to child behavior changes, we plan to utilize real-time data reporting methods such as ‘ecological momentary assessment’ using a phone or other device to capture behaviors when they occur,” added Dr. Johnstone.
Abstract
Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial
Objective
To evaluate whether micronutrients (vitamins/minerals) benefit attention-deficit/hyperactivity disorder (ADHD) and irritability in a North American pediatric sample.
Method
A 3-site, 8-week, placebo-controlled, randomized clinical trial of micronutrients was conducted in nonmedicated children aged 6 to 12 years with ADHD and at least 1 impairing irritability symptom by parent report on the Child and Adolescent Symptom Inventory−5 (CASI-5). A priori−defined primary outcomes were Clinical Global Impression−Improvement (CGI-I) (CGI-I of 1 or 2 = treatment responder) and parent-rated CASI-5 composite score of ADHD, oppositional defiant, disruptive mood dysregulation, and peer conflict symptoms, including impairment scores.
Results
Of 135 randomized (mean age 9.8 years), 126 youths (93%) comprised the modified intention-to-treat population. Blinding was maintained.
For the CGI-I, 54% of the micronutrient and 18% of the placebo group were responders (risk ratio = 2.97, 97.5% CI = 1.50, 5.90, p < .001). CASI-5 composite scores improved significantly for both groups (p < .01), with a mean change of −0.31 (95% CI = −0.39, −0.23) in the micronutrient group and a mean change of −0.28 (95% CI = −0.38, −0.19) in the placebo group.
However, the between-group difference was not significant (mean change = −0.02; 97.5% CI = −0.16, 0.12, effect size = 0.07, p = .70). The micronutrient group grew 6 mm more than the placebo group (p = .002). No serious adverse events or clinically significant changes from baseline in blood and urine tests occurred.
Conclusion
Micronutrients showed global benefit over placebo by blinded clinician rating, but not by parent-report CASI-5 composite rating in a population with ADHD and irritability. Micronutrients showed greater height growth. Micronutrients were well tolerated, and the majority of participants adhered to the number of capsules prescribed.
This randomized controlled trial replicates safety and efficacy reported for ADHD in 2 smaller trials of a similar formula containing all vitamins and known essential minerals in amounts between the Recommended Dietary Allowance and Upper Tolerable Intake Level.
Clinical trial registration information
Micronutrients for ADHD in Youth (MADDY) Study; https://clinicaltrials.gov; NCT03252522.
About this ADHD research news
Author: JAACAP Editorial Office
Source: Elsevier
Contact: JAACAP Editorial Office – Elsevier
Original Research: Open access.
“Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youths: A Placebo-Controlled Randomized Clinical Trial” by Jeanette Johnstone et al. Journal of the American Academy of Child & Adolescent Psychiatry
