Tocotrienols for School-going Children With ADHD (TOCAT)

RCSI & UCD Malaysia Campus

Status and phase: Completed; Phase 3; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Oral mixed tocotrienols

Study type: Interventional

Funder types: Other

Identifiers

NCT01855984

NMRR-6767

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

160 participants in 2 patient groups, including a placebo group

Oral mixed tocotrienols

Experimental group

Description:

2 capsules containing 100mg mixed tocotrienols per capsule taken orally once a day for 6 months

Treatment:

Dietary Supplement: Oral mixed tocotrienols

Placebo

Placebo Comparator group

Description:

2 capsules containing soya bean oil taken orally once a day for 6 months

Treatment:

Dietary Supplement: Placebo