Attention Deficit Disorder With HyperactivityPhase 2/3TOCATNCT01855984
Tocotrienols for School-going Children With ADHD
A Phase 2/3 study testing Oral mixed tocotrienols in people with Attention Deficit Disorder With Hyperactivity, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Oral mixed tocotrienols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2012to Jun 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
- Co-existing chronic liver disease
- Current use of anticoagulant or antiplatelet drugs.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang
George Town, Pulau Pinang, 10990
About this study
Official title: Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial
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.
Read the detailed description
The main objective of the study is to:
- 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.
- Being tested
- Oral mixed tocotrienols, Placebo
- Keywords
- ADHD, Children, Tocotrienol
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral mixed tocotrienolsDietary supplement
Also called Tocovid Suprabio.
200mg per day
PlaceboDietary supplement
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
| Study group | Role | What they receive |
|---|---|---|
| Oral mixed tocotrienols | Experimental | 2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months Receives: Dietary Supplement: Oral mixed tocotrienols |
| Placebo | Placebo comparator | 2 capsules containing soya bean oil taken orally once a day for 6 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales
Measured: Change of total symptom scores from baseline at 6 months
Secondary outcomes (3)
Change in the dose of current medication for ADHD
Measured: After 6 months intervention
Number of participants with adverse reaction
Measured: 6 months
Blood tocotrienol levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RCSI & UCD Malaysia Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Penang Hospital, Malaysia
- Responsible party
- Principal investigator, May Loong Tan, RCSI & UCD Malaysia Campus
- Investigators
- May Loong Tan, MRCPCH(UK), Principal investigator, RCSI & UCD Malaysia Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855984
- Sponsor's protocol ID
- NMRR-6767
- Acronym
- TOCAT
- Status last verified
- Jun 2013
- First submitted
- 10 May 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01855984
- Acronym / sponsor ID
- TOCAT / NMRR-6767
- Keywords
- ADHD, Children, Tocotrienol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RCSI & UCD Malaysia CampusUniversity, hospital or other
- Collaborators
- Penang Hospital, Malaysia
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral mixed tocotrienols | Experimental | Dietary Supplement: Oral mixed tocotrienols2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 capsules containing soya bean oil taken orally once a day for 6 months |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
- Co-existing chronic liver disease
- Current use of anticoagulant or antiplatelet drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral mixed tocotrienolsAlso: Tocovid Suprabio.200mg per day | Dietary supplement | Oral mixed tocotrienols |
| PlaceboCapsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules | Dietary supplement | Placebo |
Primary outcome
ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales
Time frame: Change of total symptom scores from baseline at 6 months
3 secondary outcomes
Change in the dose of current medication for ADHD
Time frame: After 6 months intervention
Number of participants with adverse reaction
Time frame: 6 months
Blood tocotrienol levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Loong Tan, MRCPCH(UK) principal investigator
RCSI & UCD Malaysia Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral mixed tocotrienols in people with Attention Deficit Disorder With Hyperactivity, run by RCSI & UCD Malaysia Campus at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales (time frame: Change of total symptom scores from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.