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

June 17, 2008
June 17, 2008
July 2008
July 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children
Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
ADHD
  • Dietary Supplement: PS-Omega3 conjugate supplementation
  • Dietary Supplement: placebo
  • Active Comparator: 1
    Patients receiving active product
    Intervention: Dietary Supplement: PS-Omega3 conjugate supplementation
  • Placebo Comparator: 2
    Patients receiving placebo
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
45
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
8 Years to 13 Years
No
Contact: Nachum Vaisman, Prof' 972-3-697-4807 vaisman@tasmc.health.gov.il
Israel
 
NCT00700323
TASMC-08-NV-263, 263-08-TLV
No
Yoni Manor STUDY PROJECT MANAGER, Enzymotec Ltd.
Tel-Aviv Sourasky Medical Center
Enzymotec
Principal Investigator: Nachum Vaisman, Prof' Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP