Clinical trial NCT01795040: Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD
Official title: Efficacy of a Supplementary Balanced Diet With Omega-3/ Omega-6 Fatty Acids Among 3-6 Year Olds With Symptoms of ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children With ADHD Symptoms >90th Percentile (FBB-ADHS-V); no Beginning or Completion of Psychotherapeutically or Psychopharmalogical Treatment During the Study
Keywords: omega-3/omega-6 fatty acids
Pre-school children with ADHD symptoms
randomized controlled trial
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers
timeFrame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
Secondary outcomes:
measure: Change in ODD symptoms -parent/ teacher rated (FBB-ADHD-V)
timeFrame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
measure: Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)
timeFrame: Change from pre- assessment to post assessment four months after treatment begin.
measure: Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV)
timeFrame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin
measure: Change in intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC)
timeFrame: Change from pre- assessment to post assessment four months after treatment begin.
Other outcomes:
measure: finger prick test to measure the PUFA blood concentration
timeFrame: Change from pre- assessment to post assessment four months after treatment begin
Locations:
city: Cologne
country: Germany
facility: Department of Child and Adolescent Psychiatry at the University Cologne
Study officials:
affiliation: Department of Child and Adolescent Psychiatry Univ. Cologne
name: Manfred Doepfner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: