Tocotrienols for School-going Children With ADHD
TOCAT
Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 14, 2013
June 1, 2013
1.3 years
May 10, 2013
June 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales
Change of total symptom scores from baseline at 6 months
Secondary Outcomes (3)
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
Study Arms (2)
Oral mixed tocotrienols
EXPERIMENTAL2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months
Placebo
PLACEBO COMPARATOR2 capsules containing soya bean oil taken orally once a day for 6 months
Interventions
200mg per day
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
- Co-existing chronic liver disease
- Current use of anticoagulant or antiplatelet drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RCSI & UCD Malaysia Campuslead
- Penang Hospital, Malaysiacollaborator
Study Sites (1)
Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
May Loong Tan, MRCPCH(UK)
RCSI & UCD Malaysia Campus
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 17, 2013
Study Start
February 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 14, 2013
Record last verified: 2013-06