The Effects of DHA on Attention Deficit and Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

— DADA  

Official title:

The Effects of DHA (DOCOSAHEXAENOIC ACID) on Attention Deficit and Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796262
• Other study ID #: EM-00-11
• Status: Completed
• Phase: Phase 3
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• docosahexaenoic acid
Supplementation with DHA Richoil 250mg pearl b.i.d. for six months
• Wheat germ oil
Wheat germ oil 250 mg pearl b.i.d. for six months

Locations

Country	Name	City	State
Italy	IRCCS Eugenio Medea	Bosisio Parini	Lecco

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	DMF srl (Dietetic Metabolic Food)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Functional Neuroimaging (functional Near-Infrared Spectroscopy)	Changes in the concentration of oxygenated Hb and deoxygenated Hb in prefrontal cortex during a computerized visual working memory task	Baseline and month 4
Other	Change in Cognitive Measure (ANT)	Amsterdam Neuropsychological Task	Baseline, month 4, and month 6
Other	Change in Fatty Acid blood level	Fatty Acid blood level	Baseline, month 4, and month 6
Primary	Change in ADHD RS-IV total score	ADHD rating scale IV Parent Version-Investigator completed	Baseline, month 4, and month 6
Secondary	Change in CPRS-R	Conners Parent Rating Scale Revised	Baseline, month 4, and month 6
Secondary	Change in CGI-S	Clinical Global Impression - Severity	Baseline, month 4, and month 6
Secondary	Change in C-GAS	Children Global Assessment Scale	Baseline, month 4, and month 6
Secondary	Change in CHQ	Child Health Questionnaire Total Score	Baseline, month 4, and month 6
Secondary	Change SDQ Total Score	Strenght and Difficulties Questionnaires	Baseline, month 4, and month 6