Treatment-emerging adverse events.

ObjectivePrevious evidence has established that micronutrient capsules can improve emotion regulation in children. This three-phased randomized open-label waitlist-controlled study investigated the safety of a micronutrient powder absorbed by the oral mucosa and its effects on emotion dysregulation in 5-to-10-year-old children. The primary outcome measures were the Revised Clinician-rated Temper and Irritability Scale (CL-ARI) and the Clinical Global Impressions-Improvement Scale (CGI-I).MethodForty-eight children with moderate-to-severe symptoms of irritability were randomized to an initial treatment group (ITG) or waitlist control group (IWLG) (four-week delayed start), followed by the two groups alternating between taking the micronutrients for four weeks or having a four-week break. For the last three months of the trial, both groups took the micronutrients continuously.ResultsOverall adherence rates were high (93%). At the end of RCT phase, there were large group differences (CL-ARI; d = 1.25, p p = .040) and sweating (p = .037) at the end of RCT. By the end of the study, seven participants (14.5%) dropped out non-differentially by group (p = .22).ConclusionThe findings showed that micronutrients absorbed by the oral mucosa are a safe intervention that can effectively improve emotion dysregulation in children. Future double-blinded, randomized, placebo-controlled trials are needed to support these findings.