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临床试验/NCT01795040
NCT01795040Unknown不适用

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

University of Cologne1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in Symptom Checklist for pre-school children with ADHD symptoms (FBB-ADHS-V) total score rated by parents and teachers

时间窗: Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin

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.

次要结局

  • 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 intelligence: Sequential & Simultaneous Processing, Achievement (K-ABC)(Change from pre- assessment to post assessment four months after treatment begin.)
  • Change in Child Behavior Checklist (CBCL) and Teacher Report Form (TRF)(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)(Change from pre- assessment to post assessment four months after treatment begin and to post assessment eight months after treatment begin)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manfred Doepfner

Prof. Dr.

University of Cologne

研究点 (1)

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