Effect of Zinc on Barrett's Metaplasia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in zinc-regulated cellular proteins within Barrett's tissue
研究概览
简要总结
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:
- can this zinc administration cause molecular-level changes in the Barrett's tissue?
- are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?
详细描述
14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18-80; prior diagnosis of Barrett's esophagus -
排除标准
- •unable to provide written, informed consent; prior history of Barrett's dysplasia or esophageal adenocarcinoma; drug exclusions: hormone replacement therapy, cholestyramine, amiloride diuretics, oral quinolone antibiotics, glucocorticoids, corticosteroids, anticoagulants (other than aspirin)
研究组 & 干预措施
Zinc
干预措施: zinc gluconate (Drug)
结局指标
主要结局
Changes in zinc-regulated cellular proteins within Barrett's tissue
时间窗: in biopsy tissue after 14 days of Zn exposure
次要结局
- Changes in cellular microRNA profile; changes in protein cancer biomarkers(in biopsy tissue after 14 days of Zn exposure)
研究者
James M. Mullin, Ph.D.
Professor
Main Line Health