Suspended

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

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What is being tested

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

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

Dietary Supplement
Who is being recruted

From 3 to 6 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: September 2010
See protocol details

Summary

Principal SponsorUniversity of Cologne
Study ContactManfred Doepfner, Prof. Dr.More contacts
Last updated: March 16, 2017
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Study start date: September 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Cologne
Study ContactManfred Doepfner, Prof. Dr.More contacts
Last updated: March 16, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Age: 3 - 6 years

Parents have a command of the German language

Screening score > 90th percentile in a combined parent and teacher screening questionnaire

Visit of a preschool (Kindergarten)

3 exclusion criteria prevent from participating
Consumption of fish oil-capsules

Consumption of omega fatty acids preparation

Hypersensitivity or inability to components of the study product (fish oil, primrose oil, natural strawberry flavouring, bovine gelatine)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
Placebo without PUFAs

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Child and Adolescent Psychiatry at the University Cologne

Cologne, GermanyOpen Department of Child and Adolescent Psychiatry at the University Cologne in Google Maps
SuspendedOne Study Center