Trial reportPloS one2024
Micronutrients absorbed via the oral mucosa reduce emotion dysregulation in 5-10-year-old children: A three-phased randomized wait-list-controlled trial.
Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Multinutrient Supplementation in Children With ADHD Reduced Pro- and Anti-Inflammatory Immune Factors in the MADDY Randomized Controlled Trial.Journal of attention disorders · 2026Trial
- Review
- Annual Research Review: Micronutrients and their role in the treatment of paediatric mental illness.Journal of child psychology and psychiatry, and allied disciplines · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 < .001), and 67% in the ITG and 8% in the IWLG were 'much' or 'very much' improved (CGI-I). Further, the ITG displayed a clinically meaningful reduction in Attention Deficit/Hyperactivity Impulsivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD) symptoms as measured with the Child Swanson, Nolan, and Pelham-IV Questionnaire 26 (SNAP-IV) compared to IWLG. The treatment effect regressed when participants stopped taking the micronutrients and was reinstated when participants were taking the micronutrients. The observed benefits were maintained over a sustained time period. The IWLG reported significantly more headaches (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.
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