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The Effects of DHA on Attention Deficit and Hyperactivity Disorder (DADA)
The Effects of DHA (DOCOSAHEXAENOIC ACID) on Attention Deficit and Hyperactivity Disorder
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Lecco
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Bosisio Parini, Lecco, Italië, 23842
- IRCCS Eugenio Medea
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Wheat germ oil
Wheat germ oil 250 mg pearl b.i.d. for six months
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Wheat germ oil 250 mg pearl b.i.d. for six months
Andere namen:
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Actieve vergelijker: docosahexaenoic acid
DHA Richoil 250 mg pearl (DMF srl): b.i.d. for six months
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Supplementation with DHA Richoil 250mg pearl b.i.d. for six months
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in ADHD RS-IV total score
Tijdsspanne: Baseline, month 4, and month 6
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ADHD rating scale IV Parent Version-Investigator completed
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Baseline, month 4, and month 6
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in CPRS-R
Tijdsspanne: Baseline, month 4, and month 6
|
Conners Parent Rating Scale Revised
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Baseline, month 4, and month 6
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Change in CGI-S
Tijdsspanne: Baseline, month 4, and month 6
|
Clinical Global Impression - Severity
|
Baseline, month 4, and month 6
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Change in C-GAS
Tijdsspanne: Baseline, month 4, and month 6
|
Children Global Assessment Scale
|
Baseline, month 4, and month 6
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Change in CHQ
Tijdsspanne: Baseline, month 4, and month 6
|
Child Health Questionnaire Total Score
|
Baseline, month 4, and month 6
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Change SDQ Total Score
Tijdsspanne: Baseline, month 4, and month 6
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Strenght and Difficulties Questionnaires
|
Baseline, month 4, and month 6
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Functional Neuroimaging (functional Near-Infrared Spectroscopy)
Tijdsspanne: Baseline and month 4
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Changes in the concentration of oxygenated Hb and deoxygenated Hb in prefrontal cortex during a computerized visual working memory task
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Baseline and month 4
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Change in Cognitive Measure (ANT)
Tijdsspanne: Baseline, month 4, and month 6
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Amsterdam Neuropsychological Task
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Baseline, month 4, and month 6
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Change in Fatty Acid blood level
Tijdsspanne: Baseline, month 4, and month 6
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Fatty Acid blood level
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Baseline, month 4, and month 6
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Maria Nobile, MD, PhD, IRCCS 'Eugenio Medea'
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EM-00-11
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