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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2

Conditions: ADHD

Treatments: Dietary Supplement: placebo; Dietary Supplement: PS-Omega3 conjugate supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00700323

263-08-TLV

TASMC-08-NV-263

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Patients receiving active product

Treatment:

Dietary Supplement: PS-Omega3 conjugate supplementation

2

Placebo Comparator group

Description:

Patients receiving placebo

Treatment:

Dietary Supplement: placebo