Tocotrienols for School-going Children With ADHD

Phase 2

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity

• Registration Number: NCT01855984
• Lead Sponsor: RCSI & UCD Malaysia Campus

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:

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-17
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-13
• Last Update Posted: 2013-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales	Change of total symptom scores from baseline at 6 months

Secondary Outcome Measures

Name	Time	Method
Change in the dose of current medication for ADHD	After 6 months intervention
Number of participants with adverse reaction	6 months
Blood tocotrienol levels	6 months

Trial Locations

Locations (1)

Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang; 🇲🇾 Georgetown, Penang, Malaysia

Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang

🇲🇾Georgetown, Penang, Malaysia