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PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children (ADHD-3)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700323
First Posted: June 18, 2008
Last Update Posted: June 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Enzymotec
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.

Condition Intervention Phase
ADHD Dietary Supplement: PS-Omega3 conjugate supplementation Dietary Supplement: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 45
Study Start Date: July 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients receiving active product
Dietary Supplement: PS-Omega3 conjugate supplementation
Placebo Comparator: 2
Patients receiving placebo
Dietary Supplement: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Parental written informed consent.
  2. Age: 13≥ years ≥8 (including).
  3. Gender: both male and female.
  4. TOVA computerized test score ≤-1.8 at baseline.
  5. Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
  6. Normal weight and height according to Israeli standards.
  7. 21 days without any treatment for ADHD symptoms, whether medication or food supplement.

Exclusion Criteria:

  1. History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
  2. Pervasive developmental disorder or Non-Verbal Learning Disability
  3. Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
  4. 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.
  5. Having a sibling already included in the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700323


Contacts
Contact: Nachum Vaisman, Prof' 972-3-697-4807 vaisman@tasmc.health.gov.il

Locations
Israel
Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel-Aviv, Israel
Contact: Nachum Vaisman, Prof'    972-3-697-4807    vaisman@tasmc.health.gov.il   
Principal Investigator: Nachum Vaisman, Prof'         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Enzymotec
Investigators
Principal Investigator: Nachum Vaisman, Prof' Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Yoni Manor STUDY PROJECT MANAGER, Enzymotec Ltd.
ClinicalTrials.gov Identifier: NCT00700323     History of Changes
Other Study ID Numbers: TASMC-08-NV-263
263-08-TLV
First Submitted: June 17, 2008
First Posted: June 18, 2008
Last Update Posted: June 18, 2008
Last Verified: June 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
ADHD
ADHD diagnosed children

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders