NCT02114632

Brief Summary

The purpose of the study is assessing the efficacy of Omega - 3 and Omega - 6 treatment in boys with Attention-Deficit/Hyperactivity Disorder (ADHD) compared with control group healthy boys.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

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

January 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

5.3 years

First QC Date

March 23, 2014

Last Update Submit

April 13, 2014

Conditions

ADHD

Keywords

ADHD, attention deficit/hyperactivity disorder, attention deficit disorder, inattention, cognitive skills, children, polyunsaturated fatty acids, PUFA

Outcome Measures

Primary Outcomes (1)

  • assessment of intensity of ADHD symptoms using neuropsychological tests and parents and teacher questionnaires in treated group according to placebo intervention

    change from baseline at 6 months

Secondary Outcomes (1)

  • assessment of adverse events.

    change from baseline at 6 months

Other Outcomes (1)

  • assessment of connection between level of fatty acids in serum and intensity of ADHD symptoms in treated group according to placebo intervention

    change from baseline at 6 months

Study Arms (2)

Polyunsaturated fatty acids

ACTIVE COMPARATOR

6 capsules of food supplement "Eye q" per day divided in two daily doses (558 mg EPA, 174 mg DHA, 60 mg GLA per day)

Dietary Supplement: Eye Q

placebo

PLACEBO COMPARATOR

6 capsules of olive oil per day divided in two daily doses.

Interventions

Eye QDIETARY_SUPPLEMENT

3 months of treatment with a polyunsaturated fatty acids or placebo. At 3 months a one-way treatment crossover of the placebo-group to active treatment was made so that both patient groups received active treatment for the remaining 3 month period.

Polyunsaturated fatty acids

Eligibility Criteria

Age8 Years - 16 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients will be boys between the ages of 8-16 years.
  • Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD confirmed by Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)
  • Patients must be of normal intelligence as assessed by the Wechsler Intelligence Scale for Children - Revised Edition (WISC-R).
  • Treatment of ADHD by such drugs as: atomoxetine, reboxetine, clonidine, desipramine or clomipramine or children with ADHD without pharmacological treatment

You may not qualify if:

  • Patients who have a documented history of Bipolar I or II disorder, psychosis or autism.
  • Patients with a history of epilepsy
  • Patients with a history of asthma treated with corticosteroids.
  • Patients with diabetes, haemorrhagic problem, hyperlipidemia, hypertension, hyperthyroidism or hypothyroidism.
  • Patients taking any psychotropic medication other than above-mentioned on a regular basis, including health-food supplements that the investigator feels have central nervous system activity, must have a washout equal of at least three months before study entry, and such medications are not allowed during the study.
  • Patients with a history of alcohol or drug abuse within the past 3 months (excessive or compulsive use as judged by the investigator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Psychiatry Department, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 00-576, Poland

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Magdalena Grygo, MD

    Medical University of Warsaw, Child and Adolescent Psychiatry Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 23, 2014

First Posted

April 15, 2014

Study Start

January 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

PL(1)