NCT01219309

Brief Summary

Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in children and adolescents. Method: Randomized placebo-controlled one-way crossover trial with 75 children and adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3 months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom severity and impairment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2004

Typical duration for phase_3

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

August 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
Last Updated

October 13, 2010

Status Verified

April 1, 2010

Enrollment Period

1.8 years

First QC Date

April 29, 2010

Last Update Submit

October 12, 2010

Conditions

ADHDReading/Writing Disorder

Keywords

Attention-deficit/hyperactivity disorderOmega 3/6 fatty acidsDevelopmental coordination disorderReading/writing difficulties.

Outcome Measures

Primary Outcomes (2)

  • ADHD-Rating Scale, Investigator-rated

    The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale

    From 0-3 months

  • ADHD-Rating Scale, Investigator-rated

    The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale

    From 3-6 months

Secondary Outcomes (2)

  • Clinical Global Impression-Severity Scale

    From 0-3 months

  • Clinical Global Impression-Severity Scale

    From 3-6 months

Study Arms (2)

Omega 3/6 treatment

ACTIVE COMPARATOR
Dietary Supplement: Omega 3/6 fatty acids

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo (olive oil)

Interventions

Omega 3/6 fatty acidsDIETARY_SUPPLEMENT

3 capsules bid orally

Also known as: eyeq
Omega 3/6 treatment
Placebo (olive oil)DIETARY_SUPPLEMENT

3 capsules bid orally

Placebo

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 8-18 years
  • Met DSM-IV criteria for a diagnosis of ADHD of any subtype

You may not qualify if:

  • Autism
  • Psychosis
  • Bipolar disorder
  • Mental retardation
  • Uncontrolled seizure disorder
  • Hyper- or hypothyroidism
  • Significant other medical conditions
  • Weight below 20 kg
  • Alcohol or drug abuse or the use in the past three months of any psychoactive drugs or Omega 3 preparations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Johnson M, Mansson JE, Ostlund S, Fransson G, Areskoug B, Hjalmarsson K, Landgren M, Kadesjo B, Gillberg C. Fatty acids in ADHD: plasma profiles in a placebo-controlled study of Omega 3/6 fatty acids in children and adolescents. Atten Defic Hyperact Disord. 2012 Dec;4(4):199-204. doi: 10.1007/s12402-012-0084-4. Epub 2012 Jul 3.

    PMID: 22753087DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMotor Skills Disorders

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mats Johnson, MD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2010

First Posted

October 13, 2010

Study Start

August 1, 2004

Primary Completion

June 1, 2006

Study Completion

April 1, 2007

Last Updated

October 13, 2010

Record last verified: 2010-04