Effect of Long Chain Polyunsaturated Fatty Acids on Behav... | NCT01055119

Studies
Effect of Long Chain Polyunsaturated Fatty Acids on Behavior and Cognition in Children With Attention Deficit Hyperactivity Disorder

NCT01055119

Sponsor

University of Ulm

Status

Completed

Last Update Posted

May 3, 2013Estimated

Enrollment

95Actual

Phase

Not Applicable

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Omega-3 fatty acids

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jan 22, 2010

First Submission Date that Met QC Criteria

Jan 22, 2010

First Posted Date

Jan 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2013

Last Update Posted Date

May 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katharina Widenhorn-Mueller, Katharina Widenhorn-Mueller, PhD, University of UlmPrincipal Investigator

Lead Sponsor

University of UlmOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega-3 fatty acids	Active Comparator		Dietary Supplement: Omega-3 fatty acids
Olive oil	Placebo Comparator		Dietary Supplement: Omega-3 fatty acids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 fatty acids	Dietary Supplement	duration: 4 month	Olive oil Omega-3 fatty acids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Behavior, Cognition		Before intervention and 16 weeks after start of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ADHD diagnosis
Age 9-12y
Native German speaker

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bode Harald, MD	Sozialpädiatrisches Zentrum und Kinderneurologie Universitätsklinik für Kinder- und Jugendmedizin, Ulm University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik fuer Psychiatrie und Psychotherapie III		Ulm	Baden-Wurttemberg	89075	Germany
Universitaet Ulm Klinik fuer Psychiatrie und Psychotherapie III

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015525	Fatty Acids, Omega-3

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided