Tocotrienols for School-going Children With ADHD (TOCAT)

June 13, 2013 updated by: May Loong Tan, RCSI & UCD Malaysia Campus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Penang
      • Georgetown, Penang, Malaysia, 10990
        • Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oral mixed tocotrienols
2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months
Dietary supplement: Oral mixed tocotrienols
200mg per day
Other Names:
  • Tocovid Suprabio.
PLACEBO_COMPARATOR: Placebo
2 capsules containing soya bean oil taken orally once a day for 6 months
Dietary supplement: Placebo
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 of total symptom scores from baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the dose of current medication for ADHD
Time Frame: After 6 months intervention
After 6 months intervention
Number of participants with adverse reaction
Time Frame: 6 months
6 months
Blood tocotrienol levels
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RCSI & UCD Malaysia Campus

Collaborators

Penang Hospital, Malaysia

Investigators

  • Principal Investigator: May Loong Tan, MRCPCH(UK), RCSI & UCD Malaysia Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (ESTIMATE)

May 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-6767

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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