NCT01855984已完成2 期
Tocotrienols Supplementation in School Going Children With Attention Deficit/Hyperactivity Disorder(ADHD) - A Randomized Controlled Trial
RCSI & UCD Malaysia Campus2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales
研究概览
简要总结
The purpose of this study is to determine if tocotrienol supplementation given to school going children with ADHD will result in reduction of their ADHD symptoms.
详细描述
The main objective of the study is to:
a. Determine if supplementation of tocotrienol compared to placebo has an effect on the symptoms of school going children with ADHD.
The secondary objective is to:
- Determine if supplementation of tocotrienol compared to placebo has an effect on the dose of current medication used in school going children with ADHD.
- Determine the safety of tocotrienol in the study population.
- Determine if tocotrienol levels in children with ADHD correlate with their symptom scores.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ADHD in accordance with the Diagnostic and Statistical Manual (DSM) IV criteria.
- •Be able to swallow soft gel capsules.
- •If already on medication for ADHD, the dose of the medication must be stable for the last 3months
- •Be able to attend all follow up visits.
- •Be agreeable to have their teacher score the National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale - Teacher Informant
- •Be willing to have their blood taken 3 times during the study.
排除标准
- •ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
- •Co-existing chronic liver disease
- •Current use of anticoagulant or antiplatelet drugs.
结局指标
主要结局
ADHD symptom scores as measured by NICHQ Vanderbilt Parent and Teacher Assessment Scales
时间窗: Change of total symptom scores from baseline at 6 months
次要结局
- Change in the dose of current medication for ADHD(After 6 months intervention)
- Number of participants with adverse reaction(6 months)
- Blood tocotrienol levels(6 months)
研究者
May Loong Tan
Dr
RCSI & UCD Malaysia Campus
研究点 (2)
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