The Effects of DHA on Attention Deficit and Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in
      reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample
      of children and adolescents with ADHD.
    

Detailed description: 
      The primary objective of this study is to investigate the relative efficacy and tolerability
      of omega-3 fatty acid supplementation, more specifically docosahexaenoic acid (DHA), in
      reducing attention-deficit/hyperactivity disorder (ADHD) symptoms in children. The present
      study is going to determine whether DHA supplementation induces modifications in fatty acid
      blood level and to evaluate the correlation between this possible modification and
      behavioral, neuropsychological and functional indexes. The study is a randomised,
      placebo-controlled double-blind intervention trial providing within- and between-group
      comparisons over 6 months. At the start of the study, the patients will be randomized to
      active treatment with DHA in a dose of one capsules twice daily, corresponding to a daily
      dose of 500 mg DHA, or to placebo (identical capsules with fishy odor containing 500 mg wheat
      germ oil). A total of 50 patients will be included in the study which is conducted in the
      Child Psychiatry Unit of "E. Medea" Scientific Institute (in northern Italy). The study
      participants are recruited from among patients assessed and diagnosed at this clinic, aged 6
      to 14 years, who met DSM-IV criteria for a diagnosis of ADHD of any subtype (see Eligibility
      Criteria for further details). The study will also recruit 20 typically developing children
      to provide a control group at the start of the research for comparison of fatty acid blood
      level and other outcome measures (healthy children will not be included in the
      supplementation phase).

      Clinical assessment will be made were made at three visits at the site: at baseline (Visit
      1), 4 months (Visit 2) and 6 months (Visit 3). At Visits 1-2-3, a blood sample will be taken
      for analysis of the blood fatty acid profile. At Visit 1, informed consent is signed,
      inclusion and exclusion criteria are assessed, and the investigators make a medical
      evaluation, including medical and psychiatric history, assessment of diagnosis and
      comorbidity through parent interview according to DSM-IV criteria (DAWBA). A number of other
      examinations and instruments will be used, including height and weight, pulse and blood
      pressure, a neuromotor examination and an assessment of the general level of functioning with
      clinical scales and questionnaires completed by parents (see Outcome Measure Section for more
      details); several neuropsychological tests and reading test will be performed by a
      developmental neuropsychologist. At Visits 1-2, changes in the concentration of oxygenated Hb
      and deoxygenated Hb in prefrontal cortex during a computerized visual working memory task
      will be assessed in a subset of patients (10 children from each group) with functional
      Near-Infrared Spectroscopy. Visit 2 will included the same examinations and instruments as
      Visit 1, with the exception of the reading test; Visit 3 will included all the same measures
      as Visit 1, with the exception of the fNIRS. Parents will return every month at the clinic to
      assess the compliance (defined as taking the prescribed dosage on more than 70% of the days
      in the interval), to be interviewed about current medical symptoms and any adverse events or
      side effects, and to get the supplementation dosage for the following month.
    

Intervention name(s): docosahexaenoic acid; Wheat germ oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplementation with DHA Richoil 250mg pearl b.i.d. for six months; Wheat germ oil 250 mg pearl b.i.d. for six months
Other intervention name(s): DHA Richoil (DMF srl); Wheat germ oil 250 mg pearl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; DHA; neuropsychological task; fNIRS; Docosahexaenoic Acid; n-3 polyunsaturated fatty acid; cognition; behavior