Clinical trial NCT01796262: The Effects of DHA on Attention Deficit and Hyperactivity Disorder
Official title: The Effects of DHA (DOCOSAHEXAENOIC ACID) on Attention Deficit and Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
DHA
neuropsychological task
fNIRS
Docosahexaenoic Acid
n-3 polyunsaturated fatty acid
cognition
behavior
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: DMF srl (Dietetic Metabolic Food)
First posted: 2013-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ADHD based on DSM-IV criteria and confirmed with Development and Well-Being Assessment (DAWBA) interview
* Comorbid disorder accepted: mood disorder, anxiety disorder, oppositional defiant disorder, conduct disorder, learning disorder
* Total IQ equal or above 85
* Aged from 6 to 14 years

Exclusion Criteria:

* Autism, Schizophrenia or othe psychiatric disorder not included in inclusion criteria
* associated neurologic, genetic, infectious or metabolic disorder, or a seizure disorder
* present or past use of any psychoactive drugs

Primary outcomes:
measure: Change in ADHD RS-IV total score
timeFrame: Baseline, month 4, and month 6
Secondary outcomes:
measure: Change in CPRS-R
timeFrame: Baseline, month 4, and month 6
measure: Change in CGI-S
timeFrame: Baseline, month 4, and month 6
measure: Change in C-GAS
timeFrame: Baseline, month 4, and month 6
measure: Change in CHQ
timeFrame: Baseline, month 4, and month 6
measure: Change SDQ Total Score
timeFrame: Baseline, month 4, and month 6
Other outcomes:
measure: Change in Functional Neuroimaging (functional Near-Infrared Spectroscopy)
timeFrame: Baseline and month 4
measure: Change in Cognitive Measure (ANT)
timeFrame: Baseline, month 4, and month 6
measure: Change in Fatty Acid blood level
timeFrame: Baseline, month 4, and month 6
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea
state: Lecco
Study officials:
affiliation: IRCCS 'Eugenio Medea'
name: Maria Nobile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crippa A, Tesei A, Sangiorgio F, Salandi A, Trabattoni S, Grazioli S, Agostoni C, Molteni M, Nobile M. Behavioral and cognitive effects of docosahexaenoic acid in drug-naive children with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled clinical trial. Eur Child Adolesc Psychiatry. 2019 Apr;28(4):571-583. doi: 10.1007/s00787-018-1223-z. Epub 2018 Sep 24.
citation: Crippa A, Agostoni C, Mauri M, Molteni M, Nobile M. Polyunsaturated Fatty Acids Are Associated With Behavior But Not With Cognition in Children With and Without ADHD: An Italian study. J Atten Disord. 2018 Aug;22(10):971-983. doi: 10.1177/1087054716629215. Epub 2016 Feb 9.