NCT01038024已完成不适用
A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- To establish a base line level for 5 DNA modifications of White blood cells
研究概览
简要总结
The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.
详细描述
In this pilot study, the overall purpose is to establish the molecular basis for the hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by establishing base line levels of oxidative DNA damage in a population of healthy individuals before and after taking antioxidant and mineral supplements for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health male or female non-melanoma patients or volunteers
- •18 years or older with a life expectancy greater than 6 months
- •Willing to provide pre and post blood samples to measure five DNA modifications in white blood cells
- •Willing to participate in a one tablet a day eight week supplement program and to record the ingestion of the supplement on a participant calendar
- •Must have never smoked or has not smoked for at least 6 months
- •Informed of the investigational nature of the study, is able to provide informed consent and has signed thee informed consent form
排除标准
- •Patients/healthy volunteers not meeting all of the above selection criteria.
- •Patients/healthy volunteers who have a history of kidney stones within the last 5 years.
- •Any participant with life threatening conditions including but not limited to cardiac failure, congestive heart failure, unstable coronary artery disease, uncontrolled hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe metabolic disorders and advanced cancer
- •Patients not willing to comply with protocol requirements
结局指标
主要结局
To establish a base line level for 5 DNA modifications of White blood cells
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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