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临床试验/NCT01878734
NCT01878734已完成不适用

MNP Pilot Study for Development of a Micronutrient Powder Home Fortification Program to Combat Anaemia Among Children 6-23 Months in Zambia

University of British Columbia1 个研究点 分布在 1 个国家目标入组 631 人开始时间: 2013年6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
631
试验地点
1
主要终点
Change from Baseline in the occurrence of Iron Deficiency Anemia

研究概览

简要总结

Addressing micronutrient deficiencies in Zambia is recognized as a national priority by the government due to its major contribution to morbidity and mortality among children, especially infants in their formative years. One of the most successful, cost-effective, and recommended strategy to address micronutrient malnutrition is 'in-home fortification' with micronutrient powders (Sprinkles being the most widely recognized) along with nutrition education. While this intervention has proven to be safe, effective, and efficacious in numerous other countries, a specific national protocol must be developed to maximize its effect on reducing anaemia in Zambian children. The proposed research aims to inform such protocol.

详细描述

  1. Purpose While Zambia has made progress towards reducing under-nutrition among children, as measured by underweight, other indicators of nutritional status, particularly stunting and anaemia have remained unchanged over the past decades. Repeated national surveys show that anaemia remains of public health significance among Zambian children. According to WHO classification, a prevalence of anaemia above 40% is categorized as a severe public health problem. There has been no significant reduction in anaemia among children 6-59 months over the past two decades with an estimated prevalence of 60% in 1998, 53% in 20032 and 49% in 20093. Further, younger infants were found to be more affected than older children with an estimated prevalence of 81% in children 6-18 months in 1992 and 61% in children 6-24 months in 2009. In developing countries approximately 50% of all anaemia is attributed to iron deficiency. It is further estimated that the frequency of iron deficiency is about 2.5 times that of anaemia, and when anaemia prevalence exceeds 40%, it is assumed that the entire population is suffering from some degree of iron deficiency. It is therefore assumed that this is the case with young children in Zambia. It is well established that iron deficiency has adverse health consequences even before anaemia develops. These include cognitive impairment, decreased physical capacity and reduced immunity.

The most promising strategy for this age group is 'home fortification' of staple complementary foods (foods that are consumed in addition to breast milk after 6 months of age) with small packets of Micronutrient Powders (MNP) that can be easily mixed with home-prepared food.

MNP are packed in single-serve sachets of mixed vitamins and minerals in powder form, which can be instantly sprinkled on prepared ready-to-eat complementary foods for young children without changing the colour or taste of the food. The sachets are packed to ensure that the correct amounts of micronutrients are given.

As 'stunting', low height for age, is a problem of public health significance in Zambia with 45% of children under five being stunted, this programme will specifically address practices that will help to improve nutritional intake and reduce infection in order to promote growth during the early years of life.

Therefore the purpose of this project will be to conduct a 12 month trial of MNP in the Northern Province of Zambia, in order to inform a future scale up. 2. Justification Home fortification with MNP has proved to be efficacious and effective in reducing the prevalence of iron deficiency anaemia in young children. Today, MNP are successfully used in 45-50 countries worldwide. Based on the large body of evidence available, the WHO strongly recommends the use of MNP containing at least iron, vitamin A and zinc to improve iron status and reduce anaemia in children 6-23 months of age where the prevalence of anaemia in children under two years or under five years of age is 20% or higher.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 11 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 6-11
  • Residing within the project catchment area, and plan on remaining in the same household for the 12 month study duration
  • Parent/guardian willingness to give consent for the child's participation in the study

排除标准

  • Weight-for-height Z score <3 SD
  • Mid-upper arm circumference < 11.5 cm
  • Presence of bilateral oedema
  • Severe anaemia (Hb < 7.0 g/dl)
  • HIV positive

结局指标

主要结局

Change from Baseline in the occurrence of Iron Deficiency Anemia

时间窗: One year

次要结局

  • Change from Baseline in the Occurrence of Stunting(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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