The Effect of an Oligoantigenic Diet on Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Conner's Parent Rating Scales-Revised (CRS-R)
研究概览
简要总结
Fifty patients who diagnosed as ADHD syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) Criteria aged from 6 to 16 years old will be assigned randomly into 2 arms: arm 1: the patients will follow food regimen that cover recommended daily allowance (RDA) for macronutrients and micronutrients suitable for their ages without any food restriction, arm 2: the patients will follow food regimen that cover (RDA) for macronutrients and micronutrients suitable for their ages based on Oligoantigenic diet (OAD). Psychiatric assessment will be done before intervention and after 3 months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children fulfilled DSM (5) Criteria for ADHD syndrome aged from 6 to 16 years old on stable pharmacotherapy 8 weeks prior to enrollment with intention to maintain ongoing therapies constant throughout the trial.
排除标准
- •Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
- •Intelligence quotient (IQ) of patients less than 80%.
结局指标
主要结局
Conner's Parent Rating Scales-Revised (CRS-R)
时间窗: 3 months
This tool is used to assess the profile and severity of symptoms, response to treatment and follow up studies. Items will be scored on 14 subscales of symptoms including opposition, cognitive problems, inattention and hyperactivity. It is usually considered normal when T-scores are less than 60, while scores above 60 are signs of academic, behavioral or social issues.
Clinical Global Impression
时间窗: 3 months
Scale is designed to assess the effectiveness of a particular treatment: CGI-severity scale (CGI-S) assessing illness severity and CGI-C assessing global improvement or change. CGI-S will measure illness severity at baseline and after treatment on a scale of seven points
Child Behavior Checklist (CBCL/6-18)
时间窗: 3 months
It is designed to obtain parents'/caregivers' reports of their children's problems and it is a reliable tool for assessing the traits associated with childhood mental health issues.
The Continuous Performance Test (CPT)
时间窗: 3 months
It is a measurement of sustained attention deficits. It requires participants to respond to predesignated targets among stimuli that will be presented at a rapid fixed rate.
次要结局
未报告次要终点
研究者
Haya Essam Ibrahim
lecturer of pediatrics
Ain Shams University