Tocotrienols for School-going Children With ADHD

Study Overview
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Brief Summary
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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
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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: Determine if supplementation of tocotrienol compared to placebo has an effect on the dose of current medication used in school going children with ADHD. Determine the safety of tocotrienol in the study population. Determine if tocotrienol levels in children with ADHD correlate with their symptom scores.

Official Title
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Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Dietary Supplement: Oral mixed tocotrienols
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral mixed tocotrienols<br>2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months | Dietary Supplement: Oral mixed tocotrienols<br>* 200mg per day<br>* Other names: Tocovid Suprabio.;|
| Placebo Comparator: Placebo<br>2 capsules containing soya bean oil taken orally once a day for 6 months | Dietary Supplement: Placebo<br>* Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Children, Tocotrienol