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

University of Cologne

Status: Unknown

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

Treatments: Dietary Supplement: omega-3/omega-6 fatty acids (PUFAs)

Study type: Interventional

Funder types: Other

Identifiers

NCT01795040

OMEGA-Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

omega-3/omega-6 fatty acids (PUFAs)

Experimental group

Description:

Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid

Treatment:

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

placebo without PUFAs

Placebo Comparator group

Description:

Placebo without PUFAs

Treatment:

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