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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Manfred Doepfner, University of Cologne
ClinicalTrials.gov Identifier:
NCT01795040
First received: February 16, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Supplementary Balanced Diet With Omega-3/ Omega-6 Fatty Acids Among 3-6 Year Olds With Symptoms of ADHD

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers [ Time Frame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF) [ Time Frame: Change from pre- assessment to post assessment four months after treatment begin. ] [ Designated as safety issue: No ]
    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

  • Diagnostic checklist for ADHD (DCL-ADHS) and diagnostic checklist for odd (DCL-SSV) [ Time Frame: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin ] [ Designated as safety issue: No ]
    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 in intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC) [ Time Frame: Change from pre- assessment to post assessment four months after treatment begin. ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • finger prick test to measure the PUFA blood concentration [ Time Frame: Change from pre- assessment to post assessment four months after treatment begin ] [ Designated as safety issue: No ]
    It will taken a blood sample (finger prick test) to measure the omega-3/omega-6 fatty acids levels.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Equazen Eye Q
Placebo Comparator: placebo without PUFAs
Placebo without 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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795040

Contacts
Contact: Manfred Doepfner, Prof. Dr. Manfred.doepfner@uk-koeln.de

Locations
Germany
Department of Child and Adolescent Psychiatry at the University Cologne Recruiting
Cologne, Germany
Contact: Manfred Doepfner, Prof. Dr.       Manfred.doepfner@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Manfred Doepfner, Prof. Dr. Department of Child and Adolescent Psychiatry Univ. Cologne
  More Information

No publications provided

Responsible Party: Manfred Doepfner, Prof. Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT01795040     History of Changes
Other Study ID Numbers: OMEGA-Study
Study First Received: February 16, 2013
Last Updated: April 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
omega-3/omega-6 fatty acids
Pre-school children with ADHD symptoms
randomized controlled trial

Additional relevant MeSH terms:
Efamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014