Multicenter Randomized Controlled Trial for the Evaluation of Superiority of a Supplement With Omega-3 Fatty Acids Versus Placebo for the Improvement of Attention Deficit and Hyperactivity Disorder (ADHD) in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Improvement in clinical symptoms of ADHD
研究概览
简要总结
This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.
详细描述
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of an Omega-3 Fatty Acid Supplement with EPA, DHA, vitamins E and D on ADHD clinical symptoms (according to Diagnostic and Statistical Manual for Mental Disorders, 4th. edition (DSM-IV-TR) criteria) in children between 6 and 11 years. Patients will be randomized to receive either the new omega-3 supplement or a placebo during 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 11 years 11 months.
- •ADHD diagnosis according to DSM-IV-TR criteria
- •Children whose parents are able to reliably meet all visits and all the tests required for this study based on the researcher judgment
- •Patient representative (either parents or legal guardians) must understand the conditions of the study and sign the informed consent
排除标准
- •Patients who do not meet diagnostic criteria for ADHD
- •Patients with a previously known allergy or intolerance to the components of Omega- 3 supplement
- •Patients with underlying diseases that, according to medical criteria , are not eligible for supplementation with Omega-3 fatty acids : fatty liver disease (or other liver disease), bleeding disorders and cardiovascular disease
- •Patients with allergies to fish and /or shellfish
- •Patients who have received ADHD pharmacological treatment or fatty acid supplements at any dose for more than 7 consecutive days within the last 3 months
- •Patients who have received psychological or psycho-educational treatment in the past 3 months
- •Patients who have had some kind of psychometric diagnostic tests in the last year
- •Patients with scores corresponding to a lower mental age (more than 1 year less) according to the Wechsler Intelligence Cubes Scale for Children (WISC-IV)
- •Patients with severe emotional problems according to the CAS or STAIC tests
- •Patients participating in another clinical trial
结局指标
主要结局
Improvement in clinical symptoms of ADHD
时间窗: At baseline and at 6 months
Differences between groups measured by: 1. Number of criteria of the ADHD-Scale-IV rated by parents and teachers 2. Clinical Global Impressions Scale (CGI) assessed by the physician
次要结局
- Changes in Children's Quality of Life(At baseline and at 6 months)
- Changes in neuropsychological outcomes(At baseline and at 6 months)
- Changes in emotional outcomes(At baseline and at 6 months)
- Changes in Quality of Life of Parents of Children with ADHD(At baseline and at 6 months)