Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD

Not Applicable

• Conditions: Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study
• Interventions: Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)

• Registration Number: NCT01795040
• Lead Sponsor: University of Cologne

Brief Summary

The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.

Detailed Description

The study aims at the reduction of hyperactivity, inattention and impulsivity in pre-school children aged 3-6 years, visiting a preschool, and the prevention of clinical ADHD symptoms. The 3-6 years old children will be identified by a combined parent and teacher rating ADHD-symptoms questionnaire (FBB-ADHS-V). Children with ADHD symptoms \>90th percentile will participate in a following diagnostic process. The children (n = 150) will be randomised doubleblind to a control group (taking every day four capsules Equazen eye q, containing 400 mg fish oil and 100mg evening primrose oil - EPA (372mg), DHA (116mg), GLA (40mg) and vitamin E (7.2 mg) ) or placebo group. The study is divided into two phases with four months each. After unblinding after the first phase pre-school children taking placebo receive Omega-3/Omega-6 Fatty Acids. Children (n = 75) taking verum during first four months will be randomised doubleblind to verum or placebo. In this way the progress of the behaviour symptoms will be evaluated after a significant period of time (eigth months). Clinical examination (questionnaires, intelligence test, medical examination) and evaluation of ADHD symptoms through parents and teachers with several questionnaires will be used before beginning, after four months and after eight months. In addition the pre-school children will be taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels. Additionally regular phone calls will be implemented. Medical examinations and meetings will taken place if required. If symptoms increase, children will be treated medical and/ or psychotherapeutically.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-16
• Study First Posted: 2013-02-20
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-16
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age: 3 - 6 years
• Visit of a preschool (Kindergarten)
• Parents have a command of the German language
• Screening score >90th percentile in a combined parent and teacher screening questionnaire

Exclusion Criteria

• Hypersensitivity or inability to components of the study product (fish oil, primrose oil, natural strawberry flavouring, bovine gelatine)
• Consumption of omega fatty acids preparation
• Consumption of fish oil-capsules

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
omega-3/omega-6 fatty acids (PUFAs)	omega-3/omega-6 fatty acids (PUFAs)	Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid
placebo without PUFAs	omega-3/omega-6 fatty acids (PUFAs)	Placebo without PUFAs

Primary Outcome Measures

Name	Time	Method
Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers	Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin	The FBB-ADHS-V Questionnaire is a developed parent and teacher rating scale which assesses several factors of hyperactivity, impulsivity and inattention problems in pre-school or at home.

Secondary Outcome Measures

Name	Time	Method
Change in ODD symptoms -parent/ teacher rated (FBB-ADHD-V)	Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Change in intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC)	Change from pre- assessment to post assessment four months after treatment begin.	The Kaufman Assessment Battery for Children (K-ABC) is a standardized test that assesses intelligence and achievement in children aged 2;6 to 12;6 years. It is comprised of four global test scores that include: sequential processing scales, simultaneous processing scales, achievement scales and mental processing composite. There is an additional nonverbal scale.
Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)	Change from pre- assessment to post assessment four months after treatment begin.	The CBCL and the TRF are well evaluated rating scales for the assessement of a broad spectrum of child behavioral and emotional problems as perceived by parents and teachers respectively
Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV)	Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin	The DCL-ADHD and the DCL-ODD are external assessment questionnaires. Parents were asked 18 questions to hyperactivity, impulsivity and inattention by the rater or to symptom criteria for ODD.

Trial Locations

Locations (1)

Department of Child and Adolescent Psychiatry at the University Cologne; 🇩🇪 Cologne, Germany