NCT01796262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 26, 2020

Status Verified

August 1, 2015

Enrollment Period

2.7 years

First QC Date

February 12, 2013

Last Update Submit

February 25, 2020

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDDHAneuropsychological taskfNIRSDocosahexaenoic Acidn-3 polyunsaturated fatty acidcognitionbehavior

Outcome Measures

Primary Outcomes (1)

  • Change in ADHD RS-IV total score

    ADHD rating scale IV Parent Version-Investigator completed

    Baseline, month 4, and month 6

Secondary Outcomes (5)

  • Change in CPRS-R

    Baseline, month 4, and month 6

  • Change in CGI-S

    Baseline, month 4, and month 6

  • Change in C-GAS

    Baseline, month 4, and month 6

  • Change in CHQ

    Baseline, month 4, and month 6

  • Change SDQ Total Score

    Baseline, month 4, and month 6

Other Outcomes (3)

  • Change in Functional Neuroimaging (functional Near-Infrared Spectroscopy)

    Baseline and month 4

  • Change in Cognitive Measure (ANT)

    Baseline, month 4, and month 6

  • Change in Fatty Acid blood level

    Baseline, month 4, and month 6

Study Arms (2)

Wheat germ oil

PLACEBO COMPARATOR

Wheat germ oil 250 mg pearl b.i.d. for six months

Dietary Supplement: Wheat germ oil

docosahexaenoic acid

ACTIVE COMPARATOR

DHA Richoil 250 mg pearl (DMF srl): b.i.d. for six months

Dietary Supplement: docosahexaenoic acid

Interventions

docosahexaenoic acidDIETARY_SUPPLEMENT

Supplementation with DHA Richoil 250mg pearl b.i.d. for six months

Also known as: DHA Richoil (DMF srl)
docosahexaenoic acid
Wheat germ oilDIETARY_SUPPLEMENT

Wheat germ oil 250 mg pearl b.i.d. for six months

Also known as: Wheat germ oil 250 mg pearl
Wheat germ oil

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • associated neurologic, genetic, infectious or metabolic disorder, or a seizure disorder
  • present or past use of any psychoactive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (3)

  • Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

    PMID: 37058600DERIVED

  • 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.

    PMID: 30246216DERIVED

  • 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.

    PMID: 26861157DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityBehavior

Interventions

Docosahexaenoic Acidswheat germ oil

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Maria Nobile, MD, PhD

    IRCCS 'Eugenio Medea'

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 21, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

February 26, 2020

Record last verified: 2015-08

Locations

IT(1)