NCT02348073.
Methods |
Design: parallel randomised trial Comparison: omega‐3 vs placebo |
Participants |
Inclusion criteria: 1. children aged 6 to 15 years and 11 months; 2. children of either sex (male/female) suffering from epilepsy regardless of syndrome classification; 3. children on a stable dose of antiepileptic drugs (AED) for at least 1 month prior to inclusion and for whom no change is considered a priori for the 3 months following inclusion; 4. diagnosis of ADHD inattention or mixed type according to DSM‐5 criteria; 5. children must agree to study participation, and their parents/legal guardian must provide written inform consent prior to participation in the study Exclusion criteria: 1. individuals less than 6 years or older than 16 years; 2. AED not stable for at least 1 month and/or a change in AED is expected in the 3 months following inclusion; 3. diagnosis of ADHD hyperactivity type exclusive according to DSM‐5 criteria; 4. mental retardation defined by a score < 70 on the verbal comprehension and perceptual reasoning Wechsler Intelligence Scale for Children ‐ Fourth Edition (WISC‐IV), performed within 18 months prior to inclusion or at V1; 5. diagnosis of a psychiatric comorbidity other than ADHD according to DSM‐5 criteria, including: pervasive developmental disorders including autism disorders; bipolar disorders and psychotic disorders; 6. children suffering from diabetes, any type; 7. use of psychoactive drugs in ADHD within the previous month: methylphenidate, amphetamine, atomoxetine, modafinil, and antidepressants whatever the class; 8. use of dietary supplementation other than vitamins within the last 3 months; 9. use of ketogenic diet within the last 3 months; 10. allergy to fish or other sea products; 11. soy allergy; 12. absence of coverage by social security Sample size: 77 |
Interventions |
Intervention: omega‐3; 2 capsules Vayarin twice daily, containing 8.5 mg of DHA, 21.5 mg of EPA, and 75 mg of phosphatidylserine. 2 capsules twice daily, 20 to 30 minutes prior to breakfast and dinner, for 12 weeks Control: placebo; 2 capsules twice daily, identical to the active product, which contained cellulose and a small amount of fish powder to maintain the double‐blind in odour and taste, for 12 weeks |
Outcomes |
ADHD symptoms, assessed with ADHD Rating Scale‐IV Timing of outcome assessment: 12 weeks |
Notes |
Clinical trial register: ClinicalTrials.gov (NCT02348073) Start date: 2015 Country: France Contact: Sylvain Rheims, MD, Hospices Civils de Lyon Status: completed, no results posted |