Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, Children, Tocotrienol
Brief summary
The purpose of this study is to determine if tocotrienol supplementation given to school going children with ADHD will result in reduction of their ADHD symptoms.
Detailed description
The main objective of the study is to: a. Determine if supplementation of tocotrienol compared to placebo has an effect on the symptoms of school going children with ADHD. The secondary objective is to: 1. Determine if supplementation of tocotrienol compared to placebo has an effect on the dose of current medication used in school going children with ADHD. 2. Determine the safety of tocotrienol in the study population. 3. Determine if tocotrienol levels in children with ADHD correlate with their symptom scores.
Interventions
DIETARY_SUPPLEMENTOral mixed tocotrienols
200mg per day
DIETARY_SUPPLEMENTPlacebo
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
Sponsors
Penang Hospital, Malaysia
RCSI & UCD Malaysia Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with ADHD in accordance with the Diagnostic and Statistical Manual (DSM) IV criteria. * Be able to swallow soft gel capsules. * If already on medication for ADHD, the dose of the medication must be stable for the last 3months * Be able to attend all follow up visits. * Be agreeable to have their teacher score the National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale - Teacher Informant * Be willing to have their blood taken 3 times during the study.
Exclusion criteria
* ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions. * Co-existing chronic liver disease * Current use of anticoagulant or antiplatelet drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales | Change of total symptom scores from baseline at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in the dose of current medication for ADHD | After 6 months intervention |
| Number of participants with adverse reaction | 6 months |
| Blood tocotrienol levels | 6 months |
Countries
Malaysia
Outcome results
None listed