Tocotrienols for School-going Children With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

— TOCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855984
• Other study ID #: NMRR-6767
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 10, 2013
• Last updated: June 13, 2013
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Penang Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Dietary Supplement:
• Oral mixed tocotrienols
200mg per day
• Placebo
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules

Locations

Country	Name	City	State
Malaysia	Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang	Georgetown	Penang

Sponsors (2)

Lead Sponsor	Collaborator
Penang Medical College	Penang Hospital, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales		Change of total symptom scores from baseline at 6 months	No
Secondary	Change in the dose of current medication for ADHD		After 6 months intervention	No
Secondary	Number of participants with adverse reaction		6 months	Yes
Secondary	Blood tocotrienol levels		6 months	No