Evaluation of Coenzyme q10 (Liq-nol®) Efficacy in Pediatric Patients With Down Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To measure the effects of LiQ-NOL on language skills, expressive language ability, and speech articulation.
研究概览
简要总结
The purpose of this study is to measure the effects of LiQ-NOL supplementation on language production using the Clinical Evaluation of Language Fundamentals test, language sampling using the mean length of utterance test, and speech articulation using the Goldman-Fristoe Test of Articulation.
详细描述
This is a randomized, double-blind, placebo-controlled clinical study of CoQ efficacy in a crossover design. Patients will be screened, enrolled, and studied in the outpatient clinic of the Thomas Center for Down Syndrome at CCHMC. All patients will be randomly assigned to either a liquid product (LiQ-NOL®) and an identical placebo liquid. Study drug and placebo will be administered twice a day (morning and evening).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients ranging from 6.0 years to 16 years of age.
- •Patients will have proven Trisomy
- •Females, incapable of bearing children or capable of practicing adequate birth control methods. Abstinence will be acceptable.
- •Written informed consent will be obtained from parents of all subjects prior to enrollment. Verbal assent will be obtained from all patients with DS who have sufficient decision making ability and are at least 11 years old.
排除标准
- •Patients who have insufficient mental and/or motor capacity to complete testing measures.
- •Patients less than 6 years or older than 16 years of age.
- •Patients receiving CoQ supplementation within one month prior to the study.
- •Patients with evidence of disease which may adversely affect CoQ absorption, e.g. chronic diarrhea or inflammatory bowel disease.
- •Patients participating in other research studies or having exposure to investigational drugs within one month prior to this study.
- •Females, capable of bearing children, who are unsure of their pregnancy status or not practicing adequate birth control methods.
- •Females who are pregnant.
- •Patients with a known allergy to CoQ.
- •Patients receiving drug treatment which is know to affect CoQ, e.g. cholesterol-lowering drugs such as "statins".
结局指标
主要结局
To measure the effects of LiQ-NOL on language skills, expressive language ability, and speech articulation.
时间窗: beginning and end of 3 month treatment period
次要结局
- To evaluate the effects of LiQ-NOL on child behavior.(beginning and end of 3 month treatment period)