search
Back to results

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

Primary Purpose

ADHD

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
PS-Omega3 conjugate supplementation
placebo
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, ADHD diagnosed children

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel-Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Patients receiving active product

Patients receiving placebo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 17, 2008
Last Updated
June 17, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Enzymotec
search

1. Study Identification

Unique Protocol Identification Number
NCT00700323
Brief Title
PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children
Acronym
ADHD-3
Official Title
Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Enzymotec

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, ADHD diagnosed children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients receiving active product
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
PS-Omega3 conjugate supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 21 days without any treatment for ADHD symptoms, whether medication or food supplement. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nachum Vaisman, Prof'
Phone
972-3-697-4807
Email
vaisman@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'
Phone
972-3-697-4807
Email
vaisman@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs