Status:
COMPLETED
Tocotrienols for School-going Children With ADHD
Lead Sponsor:
RCSI & UCD Malaysia Campus
Collaborating Sponsors:
Penang Hospital, Malaysia
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
- Co-existing chronic liver disease
- Current use of anticoagulant or antiplatelet drugs.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01855984
Start Date
February 1 2012
End Date
June 1 2013
Last Update
June 14 2013
Active Locations (1)
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1
Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia, 10990