Clinical trial NCT02114632: Supplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Official title: A Double Blind, Placebo Controlled Trial of Effectiveness of Omega-3 and Omega-6 Polyunsaturated Fatty Acids in Treatment of Children With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ADHD
Keywords: ADHD, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, PUFA
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 89
Sex: MALE
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy boys.

Detailed description: The study is designed as a randomized, double-blind placebo-controlled trial with a total duration of 6 months. 100-120 boys with ADHD aged 8-16 years and 30 healthy boys will will be randomized to 3 months of treatment with a fixed dose of 6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg eicosapentaenoic acid (EPA), 174 mg docosahexaenoic acid (DHA), 60 mg gamma-linolenic acid (GLA) per day) or to placebo (olive oil). At 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive active treatment for the remaining 3 month period. Control group will receive active treatment for 6 month. The assessment of children will be made 3 times: at the point of start, after 3 months, and after 6 months. The assessments will be made using standardized interviews and questionnaires, neuropsychological tests, pediatric and neurological examination and taking a 5 ml sample of blood to assess level of polyunsaturated fatty acids (PUFA) in serum and in cell membranes of erythrocytes.

Eligibility criteria: Inclusion Criteria:

1. Patients will be boys between the ages of 8-16 years.
2. Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD confirmed by Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
3. Patients must be of normal intelligence as assessed by the Wechsler Intelligence Scale for Children - Revised Edition (WISC-R).
4. Treatment of ADHD by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with ADHD without pharmacological treatment

Exclusion Criteria:

1. Patients who have a documented history of Bipolar I or II disorder, psychosis or autism.
2. Patients with a history of epilepsy
3. Patients with a history of asthma treated with corticosteroids.
4. Patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism.
5. Patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study.
6. Patients with a history of alcohol or drug abuse within the past 3 months (excessive or compulsive use as judged by the investigator).

Primary outcomes:
measure: assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention
timeFrame: change from baseline at 6 months
Secondary outcomes:
measure: assessment of adverse events.
timeFrame: change from baseline at 6 months
Other outcomes:
measure: assessment of connection between level of fatty acids in serum and intensity of ADHD symptoms in treated group according to placebo intervention
timeFrame: change from baseline at 6 months
Locations:
city: Warsaw
country: Poland
facility: Child and Adolescent Psychiatry Department, Medical University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw, Child and Adolescent Psychiatry Department
name: Magdalena Grygo, MD
role: PRINCIPAL_INVESTIGATOR
References: