Summary
This protocol describes a 20-week double-blind, placebo-controlled randomised controlled trial investigating broad-spectrum micronutrient supplementation (including NADH, B vitamins, vitamin D3, magnesium, zinc, iron, selenium, phospholipids, and L-carnitine) on irritability in 210 children and adolescents. The study addresses a gap in evidence regarding micronutrient efficacy and tolerability for irritability across diagnostic boundaries, including both ADHD and other mental health conditions, in both medicated and unmedicated youth. Primary outcomes include responder status on the CGI-I and clinically meaningful reduction in parent-rated affective reactivity.
UK applicability
The findings will be relevant to UK clinical practice and policy regarding non-pharmacological interventions for irritability in young people, particularly if efficacy is demonstrated. However, applicability may depend on whether the micronutrient formulation is accessible and affordable within NHS commissioning pathways in the United Kingdom.
Key measures
Clinical Global Impression Scale of Improvement (CGI-I) responder status at week 10 (scores 1–2); ≥30% parent-rated Affective Reactivity Index (ARI) reduction
Outcomes reported
The study will measure irritability reduction as the primary endpoint, assessed via Clinical Global Impression Scale of Improvement (CGI-I) and parent-rated Affective Reactivity Index (ARI), in a sample of 210 children and adolescents aged 11–17.6 years, with and without ADHD, both medicated and unmedicated.
Topic tags
Dig deeper with Pulse AI.
Pulse AI has read the whole catalogue. Ask about this record, its theme, or how the findings apply to UK farming and policy — every answer cites the underlying studies.