Effectiveness of Iron-Fortified Milk on Iron Status and Anemia in Young Children in Mexico
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 798
- 试验地点
- 2
- 主要终点
- Anemia
研究概览
简要总结
Iron deficiency and anemia in infants and young children impair neurodevelopment. Efficacious interventions for reducing the prevalences of iron deficiency and anemia, under controlled conditions, are available. However, little information is published about the effectiveness of large-scale programs.
Objective. Assess the effectiveness on iron deficiency and anemia in young children of a large-scale program that provides iron fortified milk at a subsidized price to low income households. Design, Setting, and Sampling. A randomized effectiveness study in 12 milk distribution clusters randomly selected from 542 clusters in 4 States in Mexico. Selected clusters were randomly assigned to receive iron-fortified milk FM, N=7) or non-fortified milk (NFM, N=5). Over 95% program beneficiaries with children 12-30 mo of age in the 12 clusters (490 in FM and 275 in NFM) were enrolled in the FM and NFM interventions and participated in a baseline survey. 635 children (405 in FM and 230 in NFM) and 584 children (371 in FM and 213 in NFM) completed the 6 and 12-mo follow-up surveys, respectively. Intervention: A daily portion of FM contained 5.28 mg of iron, 48 mg of sodium ascorbate and other added micronutrients. The FM and NFM were distributed to beneficiaries at a subsidized price in Milk Distribution Centers in the 12 clusters.
Main outcome measures: Mild-to-moderate anemia (Hb: 90-109 g/L), mild anemia (Hb: 100-109 g/L), moderate anemia (Hb: 90-99 g/L),iron deficiency: Serum Ferritin (SF) <12 ug/L and soluble transferring receptors (sTfR) >6 mg/L.Serum Zinc deficiency (< 65ug/dL), and stunting (<2SD Height/Age.
Intervention effects at 6 and 12 moths were assessed using General Linear Mixed Models with three repeated measures.
详细描述
Introduction. Iron deficiency anemia is the most common nutritional deficiency worldwide (1-3).Children less than 5 years are the most affected(4). Almost 24% of Mexican children 1-4 years of age are anemic and 52% iron deficient (5). The peak prevalence of anemia (38%) occurs in children 12-23 months of age (6). The prevalence is higher in low socioeconomic households (29 %) but remains high even in the highest quintile (17%). Anemia and iron deficiency in infants and young children are associated with adverse effects on neurodevelopment (7-12).
During several decades, the Mexican government has sold whole milk at subsidized prices to low income households with children 1-11 y of age through a federal program (Liconsa). In 2000 a decision was made to fortify the subsidized milk with iron, vitamin C and other micronutrients to contribute to the reduction of IDA and other micronutrient deficiencies. At that time, 4.2 million children 1-11 y old from low income families were beneficiaries of the program. There are very few examples of large scale public health interventions using iron fortified whole milk.
The effectiveness of interventions such as food fortification for reducing anemia and iron deficiency is often questioned (14) and little information is available on the effectiveness of these strategies implemented through large scale programs. Reliable evidence of the effectiveness of these strategies applied in large-scale programs is needed for planning interventions aimed at reducing the prevalence of iron and zinc deficiencies and anemia in children.This study aims to document the effectiveness on iron and zinc deficiencies,anemia and stunting, in young children of a large-scale program that distributes iron and zinc fortified milk to low income households at subsidized prices.
Methods The subsidized milk distribution program. The program was created in 1944 and is operated by a public organization (Liconsa)(15). It distributes whole milk at subsidized prices to families living in poverty. The milk distributed is intended mostly for children 1-11 y.
It is distributed in milk distribution centers throughout the Country as dry powder in 240 g sachets which yield two liters of fluid milk after hydration or as a 1 L container of fluid milk. Children receive the equivalent of 400 mL of fluid milk per day either in dry or fluid form for reducing the prevalence of iron deficiency anemia and other micronutrient deficiencies, through the fortification of the product with iron, zinc, vitamin C and micronutrients that were deficient in the diet of low income children in Mexico (5, 16). The program serves approximately 5 million individuals of which about 4.2 million are children <11 years and about 650,000 were children 12-30 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 12 Months 至 30 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children 12-30 months of age who were beneficiaries of the program in the 12 milk distribution clusters
排除标准
- •Children with severe anemia (Hb concentrations < 90 g/L)
结局指标
主要结局
Anemia
时间窗: 12 months
Iron deficiency
时间窗: 12 months
次要结局
- Zinc deficiency(12 months)
- Stunting(12 months)
