A Pilot Study of Choline and Betaine Supplementation in Arsenic-exposed Individuals in Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Urinary % Monomethyl Arsenic
研究概览
简要总结
Roughly 140 million people worldwide are chronically exposed to As-contaminated drinking water at concentrations exceeding the World Health Organization (WHO) standard of 10 µg/L. Arsenic is a class I carcinogen known to cause several types of cancer and ischemic heart disease. Metabolism of inorganic As (InAs), which facilitates urinary As excretion, relies on one-carbon metabolism and involves two methylation steps; both utilize S-adenosylmethionine (SAM) as the methyl donor. SAM biosynthesis relies on B vitamins including folate and B12 for the recruitment and transfer of methyl groups, but other nutrients, including choline and betaine, also contribute to the methyl pool. Our recent findings from a cross-sectional study of Bangladeshi adults exposed to a wide range of As concentrations in drinking water show that plasma choline and betaine concentrations are positively associated with As methylation. These findings suggest that choline and/or betaine may play an important role in As methylation and elimination and that simple interventions may have therapeutic potential for the many populations at risk for As-induced health effects.
The investigators aim to recruit and follow 60 participants for this pilot study which will allow us to 1) assess the acceptance of choline and betaine supplements, 2) monitor participants for any potential side effects, 3) identify any difficulties that might be encountered in daily follow-up, and 4) generate preliminary data regarding the effects of choline and/or betaine supplementation on arsenic methylation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-65
- •Absence of all exclusion criteria
排除标准
- •women who are currently pregnant at the time of recruitment and/or plan to become pregnant within 2 months
- •individuals taking nutritional supplements at the time of recruitment
- •individuals who have taken nutritional supplements within the last 3 months
- •participants enrolled in any other clinical trial
- •women who are currently breastfeeding
- •individuals known to have coronary heart disease, cerebrovascular disease, hypertension, renal disease, chronic obstructive pulmonary disease, asthma, cancer, or liver disease
- •participants with protein or glucose in their urine sample (dipstick test)
- •individuals whose drinking water history is complete for < 3 months
研究组 & 干预措施
Placebo
Placebo tablets
干预措施: Placebo (Other)
Choline bitartrate
Choline bitartrate 700 mg by mouth daily
干预措施: Choline bitartrate (Drug)
Betaine
Betaine 1000 mg by mouth daily
干预措施: Betaine (Drug)
Choline bitartrate + Betaine
Choline bitartrate 700 mg + Betaine 1000 mg daily
干预措施: Choline bitartrate + Betaine (Drug)
结局指标
主要结局
Change in Urinary % Monomethyl Arsenic
时间窗: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Change in Urinary % Inorganic Arsenic
时间窗: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
Change in Urinary % Dimethyl Arsenic
时间窗: From baseline to 8 weeks after the start of the intervention (week 8 - baseline)
次要结局
未报告次要终点
研究者
Megan Hall
Assistant Professor of Epidemiology
Columbia University
