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Tocotrienols for School-going Children With ADHD (TOCAT)

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Oral mixed tocotrienols
Placebo
Sponsored by
RCSI & UCD Malaysia Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Children, Tocotrienol

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral mixed tocotrienols

Placebo

Arm Description

2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months

2 capsules containing soya bean oil taken orally once a day for 6 months

Outcomes

Primary Outcome Measures

ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales

Secondary Outcome Measures

Change in the dose of current medication for ADHD
Number of participants with adverse reaction
Blood tocotrienol levels

Full Information

First Posted
May 10, 2013
Last Updated
June 13, 2013
Sponsor
RCSI & UCD Malaysia Campus
Collaborators
Penang Hospital, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT01855984
Brief Title
Tocotrienols for School-going Children With ADHD
Acronym
TOCAT
Official Title
Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RCSI & UCD Malaysia Campus
Collaborators
Penang Hospital, Malaysia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Children, Tocotrienol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral mixed tocotrienols
Arm Type
Experimental
Arm Description
2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules containing soya bean oil taken orally once a day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral mixed tocotrienols
Other Intervention Name(s)
Tocovid Suprabio.
Intervention Description
200mg per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in the dose of current medication for ADHD
Time Frame
After 6 months intervention
Title
Number of participants with adverse reaction
Time Frame
6 months
Title
Blood tocotrienol levels
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May Loong Tan, MRCPCH(UK)
Organizational Affiliation
RCSI & UCD Malaysia Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang
City
Georgetown
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia

12. IPD Sharing Statement

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Tocotrienols for School-going Children With ADHD

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