Thinking Zinc: A Study of Zinc Supplementation to Ameliorate Adverse Effects of Mine Waste Exposure on the Navajo Nation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Metal biomonitoring to compare change from baseline versus zinc supplement
研究概览
简要总结
This is a study to assess the effect of dietary zinc supplementation to mitigate biomarkers of metal toxicity in exposed tribal populations.
详细描述
Communities living in proximity to abandoned uranium mines have documented exposures to metals in drinking water, soil and dust. Exposure to these metals, principally uranium and arsenic, and metal mixtures is associated with dysregulation of immune function and other health effects. The objective of this study is to conduct an intervention trial to assess the effect of dietary zinc supplementation to mitigate the toxicity of metal exposures. The current project is part of a larger research effort funded by the NIH Superfund Program to study environmental metals exposures in tribal communities in New Mexico.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women between the ages of 21 and 64 years of age
- •Lives in or near the participating communities of Blue Gap-Tachee Arizona or Red Water Pond Road Community New Mexico
- •Willing to provide blood and urine samples
- •Willing to attend study visits on scheduled dates
- •Willing to take a daily zinc supplement
排除标准
- •Women who are pregnant or nursing or women who plan to become pregnant during the course of the study.
- •Individuals who have self-reported diabetes, report that they are undergoing treatment for diabetes, or are currently taking medication for diabetes.
- •Known or suspected allergy to zinc.
- •Individuals previously diagnosed with syndromes of copper homeostasis (Menkes disease or Wilsons disease).
- •Individuals consuming zinc supplements or multivitamins and are unwilling to stop for the duration of the study.
研究组 & 干预措施
Single-arm cohort
Baseline experimental measurements will be collected for each individual participant twice prior to zinc supplementation (0 month and 3 month time points). After zinc supplementation, experimental measurements will be collected for each individual participant at the 6 month and 9 month time points. The zinc intervention is zinc picolinate 15 mg once per day for 6 months.
干预措施: Zinc Picolinate 15 Mg (Drug)
结局指标
主要结局
Metal biomonitoring to compare change from baseline versus zinc supplement
时间窗: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
urinary and serum metal levels to be measured by inductively coupled plasma mass spectrometry
Lymphocyte phenotyping to compare change from baseline versus zinc supplement
时间窗: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Lymphocyte phenotypes will be measured in blood samples
Cytokine level measurement to compare change from baseline versus zinc supplement
时间窗: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
A cytokine panel will be used to measure levels of multiple cytokines in blood samples
Autoantibody measurement to compare change from baseline versus zinc supplement
时间窗: Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2)
Autoantibody panel titers will be measured in blood samples
次要结局
- DNA damage assays to compare change from baseline versus zinc supplement(Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2))
- PARP activity assays to compare change from baseline versus zinc supplement(Visit 1 (0 months-baseline 1), Visit 2 (3 months-baseline 2), Visit 3 (6 months-zinc 1), Visit 4 (9 months-zinc 2))