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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01796262
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
DMF srl (Dietetic Metabolic Food)
Information provided by (Responsible Party):
IRCCS Eugenio Medea

Tracking Information
First Submitted Date  ICMJE February 12, 2013
First Posted Date  ICMJE February 21, 2013
Last Update Posted Date February 26, 2020
Study Start Date  ICMJE June 2012
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
Change in ADHD RS-IV total score [ Time Frame: Baseline, month 4, and month 6 ]
ADHD rating scale IV Parent Version-Investigator completed
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • Change in CPRS-R [ Time Frame: Baseline, month 4, and month 6 ]
    Conners Parent Rating Scale Revised
  • Change in CGI-S [ Time Frame: Baseline, month 4, and month 6 ]
    Clinical Global Impression - Severity
  • Change in C-GAS [ Time Frame: Baseline, month 4, and month 6 ]
    Children Global Assessment Scale
  • Change in CHQ [ Time Frame: Baseline, month 4, and month 6 ]
    Child Health Questionnaire Total Score
  • Change SDQ Total Score [ Time Frame: Baseline, month 4, and month 6 ]
    Strenght and Difficulties Questionnaires
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 20, 2013)
  • Change in Functional Neuroimaging (functional Near-Infrared Spectroscopy) [ Time Frame: Baseline and month 4 ]
    Changes in the concentration of oxygenated Hb and deoxygenated Hb in prefrontal cortex during a computerized visual working memory task
  • Change in Cognitive Measure (ANT) [ Time Frame: Baseline, month 4, and month 6 ]
    Amsterdam Neuropsychological Task
  • Change in Fatty Acid blood level [ Time Frame: Baseline, month 4, and month 6 ]
    Fatty Acid blood level
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of DHA on Attention Deficit and Hyperactivity Disorder
Official Title  ICMJE The Effects of DHA (DOCOSAHEXAENOIC ACID) on Attention Deficit and Hyperactivity Disorder
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Dietary Supplement: docosahexaenoic acid
    Supplementation with DHA Richoil 250mg pearl b.i.d. for six months
    Other Name: DHA Richoil (DMF srl)
  • Dietary Supplement: Wheat germ oil
    Wheat germ oil 250 mg pearl b.i.d. for six months
    Other Name: Wheat germ oil 250 mg pearl
Study Arms  ICMJE
  • Placebo Comparator: Wheat germ oil
    Wheat germ oil 250 mg pearl b.i.d. for six months
    Intervention: Dietary Supplement: Wheat germ oil
  • Active Comparator: docosahexaenoic acid
    DHA Richoil 250 mg pearl (DMF srl): b.i.d. for six months
    Intervention: Dietary Supplement: docosahexaenoic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01796262
Other Study ID Numbers  ICMJE EM-00-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IRCCS Eugenio Medea
Study Sponsor  ICMJE IRCCS Eugenio Medea
Collaborators  ICMJE DMF srl (Dietetic Metabolic Food)
Investigators  ICMJE
Principal Investigator: Maria Nobile, MD, PhD IRCCS 'Eugenio Medea'
PRS Account IRCCS Eugenio Medea
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP