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临床试验/NCT02429921
NCT02429921已完成不适用

Mitigating Arsenic Toxicity in Bangladeshi People by Supplementing Their Diets With High Selenium Lentils

University of Calgary2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
arsenic body burden

研究概览

简要总结

About 45 million people in Bangladesh are chronically exposed to unacceptable levels of arsenic in their drinking water. Chronic arsenic poisoning leads to cancers, and vascular diseases.

This dietary trial intends to test the potential of high-selenium lentils, consumed as lentil soup, in reducing the arsenic body burden in an exposed Bangladeshi population, and in improving the overall health status.

Arsenic-exposed families will be assigned to one of two groups. One group will eat lentils (50g/person/day) that are naturally high in selenium, the other group will receive lentils with low selenium content. This 6 months trial is randomized and double-blinded.

详细描述

Chronic arsenic (As) poisoning is a worldwide public health problem. Up to 100 million people worldwide, are chronically exposed to dangerously high concentrations of As in their drinking water and food supply. Bangladesh is facing a major public health challenge - contamination of groundwater by arsenic (As). Since tube well water contamination by As was discovered in Bangladesh in the 1990s, As in drinking water has been reduced by 40%, yet approximately 45 million Bangladeshis remain at risk from high As concentrations greater than the WHO guideline value of 10 µg/L in the well water. The annual cost to treat As related health problems in Bangladesh is currently estimated up to $77.5 million. Micronutrient-deficient (e.g. Selenium) soils lead to less nutritious local foods, which becomes a partner in crime exacerbating the toxic burden incurred by As exposure.

Selenium (Se) is a trace element that is an essential component of several metabolic pathways controlling immune function. Se and As work antagonistically in the body by competing in many biological functions. Arsenic added to animal diets has been known to counteract Se toxicity/activity in animals since the 1930s. Se interacts with As to form a complex; excessive Se excretion can occur as result of Se/As complex formation under condition of chronic As ingestion and low dietary Se ingestion. This scenario may further accelerate Se depletion. Again, since Se can form a complex with As, Se supplementation, in principle, can reduce As toxicity and also decrease effects of As exposure on many other parameters, such as oxidative stress, immunotoxicity etc.

Supplementation of Se as pills is currently used to treat arsenicosis. But pills are not often well received by people and are expensive for low-income families. Lentils are a common food in Bangladesh and the country already imports lentils from Canada. Saskatchewan (SK) grown lentils are rich in Se, mostly in form of L-selenomethionine, which is highly bioavailable. The Saskatchewan lentils have mean selenium levels between 425-672 µg/kg, with some regions where lentil selenium levels go up to 1884 µg/kg. These high Se lentils, incorporated into the daily meals of As-exposed Bangladeshi families, may help mitigate the symptoms of long-term As poisoning in a cost-effective, uncomplicated, and nutritionally beneficial way.

Red lentils for this trial were grown in Saskatchewan, Canada (Se = 854 µg/kg) and Idaho, USA (Se = 0.043 µg/kg). Other nutrients will be measured in both crops of lentils at the UofS before dispatching to families in Bangladesh. High-Se and low-Se lentils will be packed in two different coloured packets and will be given to the designated families. The investigators as well as the field staff will be blinded to the types of lentils/dahl being given to each family. 65g lentils per person/day will be measured with a cup by the female family head, who typically cooks the moshur dahl (lentil soup) daily for the whole family. 65g high-Se lentils provide 55 µg Se, which is the recommended daily allowance of 55 µg/person/day.

Sampling procedure and Data collection: At the start, at mid-term and the end of the trial (Table 1), household water samples, plus hair, blood, faeces and on-spot urine samples will be collected from each individual.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • low, moderate and high arsenic levels in tube well water, that the household uses. If tube well water exceeds the national standard of 50 ppb, families will be advised to switch to another well in their proximity with lower Arsenic levels, if available.

排除标准

  • Families that have very low arsenic levels (below US standard of 10 ppb) in their well water will not be enrolled.

结局指标

主要结局

arsenic body burden

时间窗: week 12

Urine, feces, and hair samples of participants will be tested for arsenic content.

次要结局

  • Lung inflammation test(week 12)
  • Health and compliance questionnaires(biweekly (health) for 6 months)
  • Blood pressure(week 24)
  • oxidative damage(week 24)
  • Antioxidant status(week 24)
  • serum lipid levels(week 24)
  • Body mass index(week 24)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Judit E.G. Smits

Professor

University of Calgary

研究点 (2)

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