NCT02235948Unknown2 期
Efficacy and Safety of Folic Acid Supplementation Lowering Arsenic in a Chronic, Low-level Exposed Arsenic Population: a Randomized, Double-blind, Placebo Controlled Clinical Trial.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 450
- 主要终点
- Change of urine arsenic metabolites between baseline and week 8
研究概览
简要总结
The purpose of this study is to determine whether folic acid supplementation are effective on arsenic lowering in a chronic, low-level arsenic exposed population.
详细描述
Outcome measure:
Changes of arsenic metabolites at baseline and week 8
Methods High-performance liquid chromatography (HPLC)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women more than 18 years of age and chronically exposed to arsenic (arsenic concentration of the drinking water >10ug/L);
- •Population who had no folic acid supplementation in the 2 weeks before the study;
- •Women of childbearing age agreed to use a reliable contraception method during the study;
- •Everyone volunteered to participate and signed informed consent.
排除标准
- •Pregnant or breast-feeding women;
- •Allergic to folic acid;
- •Having clearly defined allergic history;
- •Reported long-term use of folic acid and other vitamins B;
- •Having obvious signs or laboratory abnormalities which could affect the efficacy of folic acid;
- •Unsuitable to participate in the study based on the judgment of the investigators;
- •Not agree to cancel the medications which may affect serum folate concentration during the study period;
- •Subjects who plan to become pregnant during the study or move out of the area within the study period;
研究组 & 干预措施
folic acid
Experimental
folic acid supplementation placebo controlled
干预措施: folic acid supplementation (Drug)
结局指标
主要结局
Change of urine arsenic metabolites between baseline and week 8
时间窗: baseline, week 8
次要结局
未报告次要终点
研究者
Xiao Xiao
MD, PhD, professor
Wenzhou Medical University
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