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

June 17, 2008 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Tel-Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Patients receiving placebo
Dietary supplement: placebo
ACTIVE_COMPARATOR: 1
Patients receiving active product
Dietary supplement: PS-Omega3 conjugate supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Enzymotec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ANTICIPATED)

July 1, 2009

Study Completion (ANTICIPATED)

July 1, 2009

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 18, 2008

Last Update Submitted That Met QC Criteria

June 17, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-08-NV-263
  • 263-08-TLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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