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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • Recruiting
    • Department of Child and Adolescent Psychiatry at the University Cologne
    • Contact: Manfred Doepfner, Prof. Dr.; Email: Manfred.doepfner@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from pre- assessment to post assessment four months after treatment begin

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Manfred Doepfner, Prof. Dr., Department of Child and Adolescent Psychiatry Univ. Cologne

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: February 16, 2013
• First Submitted That Met QC Criteria: February 16, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; omega-3/omega-6 fatty acids; Pre-school children with ADHD symptoms
• Other Study ID Numbers: OMEGA-Study