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A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil

A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019635-36-IS
Enrollment
40
Registered
2010-05-04
Start date
2010-05-04
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Attention deficit/hyperactivity disorder MedDRA version: 12.1 Level: LLT Classification code 10003736 Term: Attention deficit/hyperactivity disorder

Interventions

Trade Name: Superba(TM) Krill Oil Pharmaceutical Form: Capsule, soft Trade Name: 18/12 Fish Oil Pharmaceutical Form: Capsule, soft

Sponsors

Aker BioMarine Antarctic AS
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: All participants are male ADHD patients of the combined type and are of age 7-11 years. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known allergy to crustacean or fish

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate changes in the brain metabolism of juvenile ADHD patients after thirteen weeks of daily doses of 4 g Superba krill oil or 4 g omega-3 enriched fish oil;Secondary Objective: To evaluate if there are changes in the brain metabolism of those who receive Superba krill oil which can be related to a decrease in ADHD symptoms as measured by EEG and/or a clinical assessment. To evaluate if there are changes in the brain metabolism of those who receive Superba krill oil which can be related to a larger decrease in ADHD symptoms as measured by EEG and/or a clinical assessment when compared to those who take in the fish oil.;Primary end point(s): EEG measurements from 40 ADHD patients before and after 13 weeks of treatment with food supplements rich of omega-3 fatty acids.

Countries

Iceland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026