Micronutrient and Chronotherapy for ADHD in children ages 6-12

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized trial conducted in Malaysia, children with ADHD are assigned to receive either Usanimals™ multivitamin-mineral supplementation with chronotherapy-based lifestyle guidance or usual care for 12 weeks. The study uses parent-reported measures like SNAP-IV and Conners to track ADHD symptoms, and also evaluates sleep patterns and gut-related outcomes. The aim is to see if improving nutrition and sleep-wake routines can influence attention and behavior in pediatric ADHD. The control group receives usual care and is offered delayed supplementation after the active period. Regulatory confirmation for pediatric dosing is pending prior to implementation.

Why it matters

Who can join: the full rules

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.

Where it's running

• UCSI University
  Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Principal investigator: Satvinder Kaur A/P Nachatar Singh, PhD — UCSI University
• Study coordinator: Shu Ly Lim, PhD
• Email: shuly.olab@gmail.com
• Phone: +60108926366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.