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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Supplementary Balanced Diet With Omega-3/ Omega-6 Fatty Acids Among 3-6 Year Olds With Symptoms of ADHD

Conditions
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Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study

Intervention / Treatment
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* Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3/omega-6 fatty acids (PUFAs)<br>Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid | Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)<br>* Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid<br>* Other names: Equazen Eye Q;|
| Placebo Comparator: placebo without PUFAs<br>Placebo without PUFAs | Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)<br>* Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid<br>* Other names: Equazen Eye Q;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers | 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. | Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Child Behavior Checklist (CBCL) and Teacher Report Form (TRF) | 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 | Change from pre- assessment to post assessment four months after treatment begin. | 
| Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV) | 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. | 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) | 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 from pre- assessment to post assessment four months after treatment begin. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3/omega-6 fatty acids, Pre-school children with ADHD symptoms, randomized controlled trial