An interventional study of omega-3/omega-6 fatty acids (PUFAs) in Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study, sponsored by University of Cologne. Status unknown at 1 site in Germany. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2017-03-16.
Sponsored by University of Cologne · Not applicable, Interventional, and Treatment
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.
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.
1,513 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 1,206 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
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Exclusion Criteria:
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)
Placebo without PUFAs
Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)
Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid
Also known as: Equazen Eye Q
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.
Time frame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Change in ODD symptoms -parent/ teacher rated (FBB-ADHD-V)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Change from pre- assessment to post assessment four months after treatment begin.
finger prick test to measure the PUFA blood concentration
It will taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels.
Time frame: Change from pre- assessment to post assessment four months after treatment begin
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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University of Cologne