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临床试验/NCT00376987
NCT00376987已完成2 期

Do Dietary Supplements of Zinc Reduce Serum Cadmium Levels in Smokers?

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2003年12月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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