Skip to content

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

Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00700323
Acronym
ADHD-3
Enrollment
45
Registered
2008-06-18
Start date
2008-07-31
Completion date
2009-07-31
Last updated
2008-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, ADHD diagnosed children

Brief summary

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

Interventions

DIETARY_SUPPLEMENTPS-Omega3 conjugate supplementation
DIETARY_SUPPLEMENTplacebo

Sponsors

Enzymotec
CollaboratorINDUSTRY
Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No

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.

Countries

Israel

Contacts

Primary ContactNachum Vaisman, Prof'
vaisman@tasmc.health.gov.il972-3-697-4807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026