NCT00382616

Brief Summary

To determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect Attention-deficit/hyperactivity disorder symptoms in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
Last Updated

November 7, 2006

Status Verified

September 1, 2006

First QC Date

September 28, 2006

Last Update Submit

November 6, 2006

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

behavioral problemslearning problemsinattentiveimpulsivehyperactivechildrenphosphatidylserinelong-chain polyunsaturated fatty acideicosapentaenoic aciddocosahexaenoic acidomega3:omega6 ratioeicosapentaenoic acid:arachidonic acid ratioTest of Variables of AttentionADHD index scores

Outcome Measures

Primary Outcomes (2)

  • Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA)

  • Blood lipids profile

Secondary Outcomes (2)

  • Hebrew translation of Conners' Parent Rating Scale-Revised, Short Form

  • Hebrew translation of the Child Behavior Checklist for Age 4-18, Parent form by Achenbach

Interventions

Phosphatidylserine-Omega3DRUG

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • and 13 years of age; diagnosed as having ADHD; otherwise healthy;

You may not qualify if:

  • significant sensory or neurological limitations, epilepsy, mental retardation, psychosis, or pervasive developmental disorder; medications with known central nervous system effects such as tranquilizers, antidepressants, stimulants (including methylphenidate and amphetamines), sedating antihistamines and some asthma medications and dietary supplements but vitamins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Unit, Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • Vaisman N, Kaysar N, Zaruk-Adasha Y, Pelled D, Brichon G, Zwingelstein G, Bodennec J. Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids. Am J Clin Nutr. 2008 May;87(5):1170-80. doi: 10.1093/ajcn/87.5.1170.

    PMID: 18469236DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityProblem BehaviorImpulsive BehaviorSpasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild BehaviorNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nachum Vaisman, MD

    Clinical Nutrition Unit, Sourasky Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

July 1, 2004

Study Completion

January 1, 2005

Last Updated

November 7, 2006

Record last verified: 2006-09

Locations

IL(1)