NCT02114632

Supplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: Male
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADHD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Eye Q	3 months of treatment with a polyunsaturated fatty acids or placebo. At 3 months a one-way treatment crossover of the placebo-group to active treatment was made so that both patient groups received active treatment for the remaining 3 month period.

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2014-04-15
• Last updated: 2014-04-15

Locations

1 site across 1 country: Poland