NCT01055119

Brief Summary

The study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

3.4 years

First QC Date

January 22, 2010

Last Update Submit

May 2, 2013

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Behavior, Cognition

    Before intervention and 16 weeks after start of intervention

Study Arms (2)

Omega-3 fatty acids

ACTIVE COMPARATOR
Dietary Supplement: Omega-3 fatty acids

Olive oil

PLACEBO COMPARATOR
Dietary Supplement: Omega-3 fatty acids

Interventions

Omega-3 fatty acidsDIETARY_SUPPLEMENT

duration: 4 month

Olive oilOmega-3 fatty acids

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADHD diagnosis
  • Age 9-12y
  • Native German speaker

You may not qualify if:

  • Allergy against fish and fish products
  • IQ below 85
  • Objections against pork gelatine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik fuer Psychiatrie und Psychotherapie III

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III

Ulm, D-89075, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Bode Harald, MD

    Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Katharina Widenhorn-Mueller, PhD

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 25, 2010

Study Start

April 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

DE(2)