Tocotrienols for School-going Children With ADHD | NCT01855984

Studies
Tocotrienols for School-going Children With ADHD

NCT01855984

Sponsor

RCSI & UCD Malaysia Campus

Status

Completed

Last Update Posted

Jun 14, 2013Estimated

Enrollment

160Estimated

Phase

Phase 2Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Interventions

Oral mixed tocotrienols
Placebo

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

May 10, 2013

First Submission Date that Met QC Criteria

May 14, 2013

First Posted Date

May 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2013

Last Update Posted Date

Jun 14, 2013Estimated

Name	Class
Penang Hospital, Malaysia	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Determine if supplementation of tocotrienol compared to placebo has an effect on the dose of current medication used in school going children with ADHD.
Determine the safety of tocotrienol in the study population.
Determine if tocotrienol levels in children with ADHD correlate with their symptom scores.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral mixed tocotrienols	Experimental	2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months	Dietary Supplement: Oral mixed tocotrienols
Placebo	Placebo Comparator	2 capsules containing soya bean oil taken orally once a day for 6 months	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral mixed tocotrienols	Dietary Supplement	200mg per day	Oral mixed tocotrienols

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
May Loong Tan, MRCPCH(UK)	RCSI & UCD Malaysia Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang		George Town	Pulau Pinang	10990	Malaysia

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided