Micronutrient Supplementation and Chronotherapy in Children With ADHD

Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children that can affect attention, behavior, learning, and daily functioning. Nutritional status, gut health, and sleep and circadian patterns may influence ADHD-related symptoms. This randomized controlled trial will evaluate the effects of a 12-week intervention combining broad-spectrum multivitamin-mineral supplementation (Usanimals™) with chronotherapy-based lifestyle guidance in Malaysian children aged 6-12 years with ADHD. The intervention includes Usanimals™ supplementation and guidance on sleep routines and meal timing. Participants will be randomly allocated to either the intervention group or a control group receiving usual care. Changes in ADHD-related symptoms will be assessed using validated parent-reported measures, including the SNAP-IV and Conners questionnaires. Sleep patterns and gastrointestinal outcomes will also be evaluated. The study aims to determine whether this combined micronutrient and lifestyle approach may improve ADHD-related symptoms, sleep, and gastrointestinal outcomes compared with usual care.

Inclusion criteria: 1. Children who meet the diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) or children with elevated parent-reported ADHD symptoms who meet at least one of the prespecified CPRS-48 or parent SNAP-IV screening thresholds at Week 0, as described in Screening and Eligibility. Children with parent-reported ASD Level 1 may also be included, provided they meet all ADHD screening and other eligibility criteria. 2. Aged 6-12 years. 3. Able to comply with the study procedures, medication schedule, and follow-up visits. 4. Written informed consent has been obtained from the parent or legal guardian. Exclusion criteria: 1. Children with Autism Spectrum Disorder (ASD) Level 2 or Level 3, or with an ASD diagnosis of unknown severity that cannot be confirmed as Level 1 based on existing information. 2. A diagnosed intellectual disability or an intelligence quotient (IQ) below 70. 3. Presence of cardiac disease or liver disease. 4. Participation in another clinical trial within the specified washout period. 5. Presence of a diagnosed bleeding disorder or significant history of abnormal bleeding. 6. Presence of any known or suspected immunocompromising condition. 7. Any medical condition (e.g., severe allergies to fish/seafood or acute systemic diseases) or behavioral condition (e.g., acute psychiatric crises) that would compromise the participant's safety or the integrity of the study data.