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Completed

NCT Number: NCT01855984

Tocotrienols for School-going Children With ADHD

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang

George Town, Pulau Pinang, 10990, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral mixed tocotrienols

Dietary Supplement

200mg per day

Other names: Tocovid Suprabio.

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Change in the dose of current medication for ADHD

    Time frame: After 6 months intervention

  2. Number of participants with adverse reaction

    Time frame: 6 months

  3. Blood tocotrienol levels

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

RCSI & UCD Malaysia Campus

Other

Collaborators

  • Penang Hospital, Malaysia

Registry information

Official study title

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

Acronym: TOCAT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 17, 2013
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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