Mitigation Efforts in Arsenic Exposure With Folic Acid Supplementation: Reducing Toxicity and Exploring the Impact on Lung Health
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Measurement of urine and blood arsenic metabolites
研究概览
简要总结
The purpose of this study is to evaluate the effects on folic acid supplementation in a population living in an environment with chronic arsenic exposure in Birmingham, Alabama.
详细描述
Folic acid supplementation effects urinary arsenic excretion. In this project investigators propose to investigate if oral folic acid dietary supplementation can increase urinary arsenic metabolite excretion
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study randomization will be performed by using a randomization scheme provided by the Investigational Drug Service (IDS). The randomization scheme will be held by IDS and concealed to investigators until the completion of the study.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •Resident of the superfund site
- •Clinically stable with no significant changes in general health status in the past 4 weeks prior to screening as assessed by the investigator
- •Provide written informed consent
排除标准
- •Pregnancy
- •Ongoing folic acid nutritional supplementation
- •Methotrexate use
- •Megaloblastic anemia
- •Alcoholic liver disease
- •Malabsorptive syndromes - celiac disease, inflammatory bowel disease
结局指标
主要结局
Measurement of urine and blood arsenic metabolites
时间窗: 12 weeks
Inorganic As (InAs) within humans undergoes a stepwise biotransformation reaction in which it is methylated to monomethyl-arsonic acid (MMAsIII), and dimethylarsinic acid (DMAsV) facilitating urinary excretion. This occurs via arsenic methyltransferase (AS3MT) using a methyl donor S-adenosylmethionine (SAM). In this pathway the one-carbon unit carried by 5-methyl-tetrahydrofolate (5-MTHF) is transferred to homocysteine to form methionine, which is activated to SAM. Complete methylation to DMAsV is critical as higher proportion of MMAs(III+V) are associated with skin lesions, peripheral vascular disease, atherosclerosis, and cancers. We will measure levels of InAs, total DMA and MMA in the urine and blood of the study subjects at baseline and 12 weeks. Outcomes will be reported in percentage (%) of InAs, DMA and MMA in blood and urine.
次要结局
- Pooled Cohort Probability Score(12 weeks)
- Respiratory Symptom Questionnaire(12 weeks)
研究者
Kevin Dsouza, MD
Assistant Professor
University of Alabama at Birmingham