Tocotrienols for School-going Children With ADHD

RCSI & UCD Malaysia Campus160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Oral mixed tocotrienolsDIETARY_SUPPLEMENT

200mg per day

PlaceboDIETARY_SUPPLEMENT

Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang

George Town, Pulau Pinang, Malaysia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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