NCT01855984

Tocotrienols for School-going Children With ADHD

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: RCSI & UCD Malaysia Campus · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral mixed tocotrienols	200mg per day
DIETARY_SUPPLEMENT	Placebo	Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-05-17
• Last updated: 2013-06-14

Locations

1 site across 1 country: Malaysia