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.
Full Title of Study: “Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) – A Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2013
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.
- Dietary Supplement: Oral mixed tocotrienols
- 200mg per day
- Dietary Supplement: Placebo
- Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
Arms, Groups and Cohorts
- Experimental: Oral mixed tocotrienols
- 2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months
- Placebo Comparator: Placebo
- 2 capsules containing soya bean oil taken orally once a day for 6 months
Clinical Trial Outcome Measures
- ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales
- Time Frame: Change of total symptom scores from baseline at 6 months
- Change in the dose of current medication for ADHD
- Time Frame: After 6 months intervention
- Number of participants with adverse reaction
- Time Frame: 6 months
- Blood tocotrienol levels
- Time Frame: 6 months
Participating in This Clinical Trial
- 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.
- ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
- Co-existing chronic liver disease
- Current use of anticoagulant or antiplatelet drugs.
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- RCSI & UCD Malaysia Campus
- Penang Hospital, Malaysia
- Provider of Information About this Clinical Study
- Principal Investigator: May Loong Tan, Dr – RCSI & UCD Malaysia Campus
- Overall Official(s)
- May Loong Tan, MRCPCH(UK), Principal Investigator, RCSI & UCD Malaysia Campus
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