Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Reversal of cadmium-induced inhibition of mismatch repair
研究概览
简要总结
RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA damage.
PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.
详细描述
OBJECTIVES:
- Determine whether zinc supplements reduce cadmium levels in smokers.
- Measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at 6 supplementation visits.
- Determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease during supplementation with VisiVite Smoker's Formula.
- Determine if increased cadmium levels in the blood of cigarette smokers can be correlated with decreased mismatch repair.
- Determine if administration of zinc-containing supplements reverses cadmium-induced inhibition of mismatch repair.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable toxicity.
Blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. Samples are examined for cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of mismatch repair proteins (MSH2, MSH6, MSH3, MLH1, and PMS2), levels of messenger RNA by reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel electrophoresis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reversal of cadmium-induced inhibition of mismatch repair
时间窗: 17 weeks
Correlation of increased cadmium levels with decreased mismatch repair
时间窗: 17 weeks
Serum levels of cotinine, zinc, and cadmium at 3 pre-supplementation visits and at 6 supplementation visits
时间窗: 17 weeks
Reduction of cadmium levels
时间窗: 17 weeks
次要结局
未报告次要终点
