NCT00700323

Brief Summary

To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 18, 2008

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 17, 2008

Last Update Submit

June 17, 2008

Conditions

ADHD

Keywords

ADHDADHD diagnosed children

Study Arms (2)

1

ACTIVE COMPARATOR

Patients receiving active product

Dietary Supplement: PS-Omega3 conjugate supplementation

2

PLACEBO COMPARATOR

Patients receiving placebo

Dietary Supplement: placebo

Interventions

PS-Omega3 conjugate supplementationDIETARY_SUPPLEMENT
1
placeboDIETARY_SUPPLEMENT
2

Eligibility Criteria

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

You may qualify if:

  • Parental written informed consent.
  • Age: 13≥ years ≥8 (including).
  • Gender: both male and female.
  • TOVA computerized test score ≤-1.8 at baseline.
  • Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
  • Normal weight and height according to Israeli standards.
  • days without any treatment for ADHD symptoms, whether medication or food supplement.

You may not qualify if:

  • History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
  • Pervasive developmental disorder or Non-Verbal Learning Disability
  • Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
  • History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
  • Having a sibling already included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nachum Vaisman, Prof'

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nachum Vaisman, Prof'

CONTACT

972-3-697-4807vaisman@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 18, 2008

Record last verified: 2008-06

Locations

IL(1)