Tocotrienols for School-going Children With ADHD

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.

Full Title of Study: “Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) – A Randomized Controlled Trial”

Study Type

  • 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

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 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

Primary 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

Secondary Measures

  • 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

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RCSI & UCD Malaysia Campus
  • Collaborator
    • 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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