Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
160 participants
INTERVENTIONAL
2012-02-29
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate NRCT-101SR in Pediatric Subjects With ADHD
NCT06215144
Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
NCT02333149
The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit Hyperactivity Disorder (ADHD)
NCT01022229
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT01458340
NT0102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
NCT01835548
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oral mixed tocotrienols
2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months
Oral mixed tocotrienols
200mg per day
Placebo
2 capsules containing soya bean oil taken orally once a day for 6 months
Placebo
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral mixed tocotrienols
200mg per day
Placebo
Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* Co-existing chronic liver disease
* Current use of anticoagulant or antiplatelet drugs.
6 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Penang Hospital, Malaysia
OTHER_GOV
RCSI & UCD Malaysia Campus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
May Loong Tan
Dr
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
May Loong Tan, MRCPCH(UK)
Role: PRINCIPAL_INVESTIGATOR
RCSI & UCD Malaysia Campus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Child & Adolescent Psychiatry Unit, Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NMRR-6767
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.