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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Enzymotec
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00700323
First received: June 17, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 17, 2008
Last Updated: June 17, 2008
Health Authority: Israel: Ministry of Health

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
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014