Efficacy of a Supplementary Balanced Diet With Omega-3/ Omega-6 Fatty Acids Among 3-6 Year Olds With Symptoms of ADHD
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
- 否
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
Manfred Doepfner
Prof. Dr.
University of Cologne
