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

NCT ID: NCT00700323

Last Updated: 2008-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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ADHD

Keywords

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ADHD ADHD diagnosed children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Patients receiving active product

Group Type ACTIVE_COMPARATOR

PS-Omega3 conjugate supplementation

Intervention Type DIETARY_SUPPLEMENT

2

Patients receiving placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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PS-Omega3 conjugate supplementation

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enzymotec

INDUSTRY

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Enzymotec Ltd.

Principal Investigators

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Nachum Vaisman, Prof'

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nachum Vaisman, Prof'

Role: CONTACT

Phone: 972-3-697-4807

Email: [email protected]

Facility Contacts

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Nachum Vaisman, Prof'

Role: primary

Other Identifiers

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263-08-TLV

Identifier Type: -

Identifier Source: secondary_id

TASMC-08-NV-263

Identifier Type: -

Identifier Source: org_study_id