Effectiveness of supplementation with Omega-3/6 fatty acid in 3-6 years old children with attention-deficit/hyperactivity symptoms

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003197

Enrollment

250

Registered

2011-08-26

Start date

2010-10-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

F90.0 F90.1

Interventions

Group 1: The first group receives in the first phase a polyunsaturated fatty acids (Omega-3/-6

Equazen IQ, 500mg/day) over a period of 4 months (randomized, double-blind). After that unblinding takes place. The group will be randomized again (phase 2 is also blind). The half of the group receiv

Equazen IQ, 500mg/day), the other half of the group receives over a period of 4 months a placebo. Group 2: The second group receives placebo over a period of 4 months (randomized, double-blind). After

Equazen IQ, 500mg/day) over a period of 4 months.

Eligibility

Sex/Gender

All

Age

3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Healthy children aged between 3-6 with visiting a kindergarden/prescholol, parents speak fluently German, at least 90. Percentile in screening of the parents and teacher

Exclusion criteria

Exclusion criteria: Intolerance to study agent or any food with fish oil or supplementation with polyunsaturated fatty acids Other treatments to reduce behavioural problems

Design outcomes

Primary

Measure	Time frame
changes in der ADHD-symptomatology: FBB-ADHD-V-total-score parents (baseline, after 4 and 8 months); changes in der ADHD-symptomatology: FBB-ADHS-V-total-score teacher (baseline, after 4 and 8 months)	—

Secondary

Measure	Time frame
changes in emotional state: CBCL 1 ½-5 (Child behavior checklist) (baseline, after 4 and 8 months) changes in sequential processing scales: K-ABC (Kaufman Assessment Battery for Children) (baseline, after 4 months); changes in simultaneous processing scales: K-ABC (baseline, after 4 months): changes in achievement scales: K-ABC (baseline, after 4 months); changes in polyunsaturated fatty acids (Omega-3/6): blood sample (baseline, after 4 months)	—

Measure

Time frame

changes in emotional state: CBCL 1 ½-5 (Child behavior checklist) (baseline, after 4 and 8 months) changes in sequential processing scales: K-ABC (Kaufman Assessment Battery for Children) (baseline, after 4 months); changes in simultaneous processing scales: K-ABC (baseline, after 4 months): changes in achievement scales: K-ABC (baseline, after 4 months); changes in polyunsaturated fatty acids (Omega-3/6): blood sample (baseline, after 4 months)

—

Countries

Germany

Contacts

Public ContactStefan Heintz

Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters

stefan.heintz@zi-mannheim.de+49 (0)621-1703 48 09

Outcome results

None listed

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