Effectiveness of Post-harvest Intervention Package in Minimizing Aflatoxins and Fumonisins Exposure to Infants and Young Children Through Maize Based Complementary Foods and Breastfeeding in Rural Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Reduction in aflatoxins and fumonisins contamination in maize and in breast milk after 6 months of intervention
研究概览
简要总结
It has been shown that exposure to mycotoxins through complementary foods and breast milk had profound effects on growth of children from 6 months to 1 year of age. In Tanzania maize is the main ingredient for complementary food, however, the crop is vulnerable to mycotoxins contamination. it has been reported that the most effective way to reduce mycotoxin exposure is to lower the mycotoxins contamination of maize. This study has developed a post-harvest intervention package for use in rural Tanzania to reduce contamination of maize and breast milk with two forms of mycotoxins; aflatoxins and fumonisins. It is composed of 5 components; 1) hand sorting, 2) drying surface, 3) proper drying 4) application of insecticide, 5) dehulling and was introduced in three main maize producing agro-ecological zones. The intervention used randomised controlled trial design where infants less than 8 six months of age were recruited and followed up 6 months after recruitment. The intervention expects to demonstrate the effectiveness of the post harvest intervention package in reducing aflatoxins and fumonisins contamination of maize and subsequent exposure of these toxins to infants and young children through maize based complementary food and breast milk. The findings will be used in developing guidelines for farmers and extension officers to reduce aflatoxins and fumonisins contamination of maize and improve the health of the infants and the whole population.
The study hypothiseses that introducing post-harvest intervention package can reduce aflatoxins and fumonisins contamination of maize and subsquent exposure of these toxins to infants and young children through maize based complementary foods and breast milk than routine agriculture extension services offered to the farmers in rural Tanzania. The specific objectives include;
- To evaluate the effectiveness of post-harvest intervention package on reduction of aflatoxins and fumonisins contamination of maize and in breast milk
- To perform exposure assessment of aflatoxins and fumonisins to infants and young children through maize based complementary food and breast milk
- To perform risk characterization of aflatoxins and fumonisins exposure to infants and young children through maize based complementary foods and breast milk
- To assess the association between exposure to aflatoxins and fumonisins and child growth
详细描述
Study sites , selection criteria and settings:
This study was conducted in three different agro-ecological zones (AEZ) of Tanzania; these are Northern Highlands, South-western Highlands and Eastern Lowland zones. For each zone, one maize-producing district, primarily for home consumption, was purposively selected, Hanang' district representing the Northern Highlands, Kilosa district represent Eastern Lowland zone and Rungwe represents the South Western Highlands. For each district, ten villages; five interventions and five control was randomly selected. From each village, 10 households were chosen. The selection criterion of the households were to be a local maize cultivars /grower, capacity of storing maize for the period not less than five to six months after harvest and having lactating mother of a child less than 8 months of age. Therefore, a total of 300 households; 100 selected from each of districts were involved in the study. The three districts each are divided into a divisions, wards and villages. A village is the lowest administrative unit and is considered as a geopolitical unit and intact social group. It has a local government authority and committees. Each village has one agriculture extension officer who is a Government employee under the Local Government Authority. The extension services provided includes the provision of farmers with knowledge, information, experiences and technologies needed to increase and sustain productivity and for improved wellbeing and livelihoods.
Design:
Study used a Cluster Randomized Controlled Trial. Villages were randomly assigned to either the intervention or control study groups. The intervention duration was 6 months. The control group continued to receive routine agriculture extension services on good practices for handling crops , an agricultural extension service for farmers offered regularly by village agriculture extension officer at vilage level. The extension services provided includes the provision of farmers with knowledge, information, experiences and technologies needed to increase and sustain productivity, avoid crop spoilage during storage for improved wellbeing and livelihoods. The intervention group received post-harvset intervention package in addition to the routine agriculture education.
Recruitment:
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
- None
入排标准
- 年龄范围
- — 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 0-8 months at the time of recruitment into the study
- •Infants currently being breastfed
- •Parents anticipated local residence, maize grower and capacity of storing maize for the period not less than six months after harvest
排除标准
- •Abnormalities impairing feeding or physical growth measurements
研究组 & 干预措施
Routine agriculture extension services
Routine agriculture extension services alone
干预措施: Routine agriculture extension services (Behavioral)
Post-harvest intervention package
Post-harvest intervention package and routine agriculture extension services
干预措施: post-harvest intervention package (Behavioral)
Post-harvest intervention package
Post-harvest intervention package and routine agriculture extension services
干预措施: Routine agriculture extension services (Behavioral)
结局指标
主要结局
Reduction in aflatoxins and fumonisins contamination in maize and in breast milk after 6 months of intervention
时间窗: after 6 months of intervention
次要结局
- The proportion of children exceeding the health based guidance value of aflatoxins and fumonisins Tolerable Daily Intake (TDI) or provisional Maximum Tolerable Daily Intake (PTWI)(after 6 months of intervention)
- Differences in weight - for- age Z-score for intervention and control groups after the intervention(after 6 months of intervention)
- Document post-harvest practices that are effective in reducing contamination of maize with aflatoxins and fumonisins(after 6 months of intervention)
研究者
Analice A. Kamala
Senior Food Risk Assessment officer
Tanzania Food and Drugs Authority