NCT00770627.
Methods |
Design: parallel randomised trial Comparison: omega‐3 vs placebo |
Participants |
Inclusion criteria: 1. children aged 6 to 15 years and 11 months, with hyperactivity confirmed by DSM‐IV criteria; 2. children and parents' consent Exclusion criteria: 1. without MPH treatment; 2. fish or other sea products allergy; 3. intake of sea omega‐3 fatty acids supplements more 1 week during 3 months before the trial; 4. children need quickly to take MPH: social, family, or school risk; 5. intake methylphenidate 30 days before the trial or/and intake it during 1 consecutive week Sample size: 160 |
Interventions |
Intervention: children between 6 and 8 years of age, 2 caps/day; children between 9 and 11 years, 3 caps/day; children between 12 and 15 years, 4 caps/day Control: placebo |
Outcomes |
ADHD symptoms, assessed with ADHD Rating Scale Timing of outcome assessment: 12 weeks |
Notes |
Clinical trial register: ClinicalTrials.gov (NCT00770627) Start date: 2008 Country: France Contact: Doctor Olivier Revol, Pierre Wertheimer Hospital Status: no updates posted |