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临床试验/NCT00210405
NCT00210405已完成不适用

Assessing the Feasibility and Effectiveness of Distributing Micronutrient Sprinkles Within a Title II Food Aid and Maternal and Child Health Program in Rural Haiti

International Food Policy Research Institute1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2005年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
1
主要终点
Prevalence of anemia after 2 months of treatment

研究概览

简要总结

The objective of this study is to test the feasibility and effectiveness of distributing micronutrient sprinkles to 6-20 month old children participating in an integrated maternal and child health and nutrition program in rural Haiti. The micronutrient sprinkles have been formulated to prevent or treat anemia in 6-23 month old children. Effectiveness in reducing the prevalence of anemia will be assessed.

详细描述

Anemia is highly prevalent among infants and young children in Haiti and throughout the world. Low intakes of several micronutrients contribute to this problem. It is very difficult to meet the micronutrient needs of infants and young children without substantial amounts of animal-source foods; such foods are not affordable for most families in many poor communities.

Micronutrient sprinkles are a novel approach to meeting children's needs. The sprinkles are packed in sachets containing a daily ration, and are intended to be used in the home and "sprinkled" directly on the children's food. Earlier trials have shown the efficacy of the sprinkles for preventing and treating anemia under controlled conditions.

The current study tests the feasibility and effectiveness when sprinkles are distributed in the programmatic context of a US Title II food aid distribution program, a context that is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study also includes the development and dissemination of educational messages to motivate and enable caregivers to use the sprinkles properly. Based on previous efficacy trials no side-effects are anticipated, but the study also monitors for unanticipated side-effects.

Comparison: Since effectiveness of the sprinkles distributed as part of a take-home ration has not been established, this study employed a randomized controlled design. Randomization occurred at the level of the food distribution point (place where community members gather to receive food rations). Groups were assigned to receive either the take home ration (usual program practice) or the take home ration and the sprinkles. Families receiving only food rations at the control sites will receive sprinkles along with their food ration immediately after data collection is complete. The design was also consistent with the program necessity of a gradual roll-out of this new intervention. The prevalence of anemia among target-age children will be compared between groups that receive a two-month supply of micronutrient sprinkles with their take-home food ration, and those that do not.

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
None

入排标准

年龄范围
6 Months 至 20 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •6-20 months old at time of recruitment
  • •Family receives food rations at World Vision-Haiti's Food Distribution Points

排除标准

  • •Severe anemia at time of recruitment (hemoglobin <7.0 g/dl)

研究组 & 干预措施

Food aid only

Active Comparator

Children in this arm received fortified food aid commodities supplied through the maternal and child health and nutrition program implemented by World Vision. They received fortified corn-soy blend, which contained iron.

干预措施: Fortified food aid (corn-soy blend) (Dietary Supplement)

Micronutrient sprinkles + food aid

Experimental

Children in this arm were enrolled in the food assisted program, and therefore received fortified food aid, as well as 60 sachets of a multiple micronutrient powder (Sprinkles) containing iron, zinc, vitamin A, vitamin C and folic acid

干预措施: "Sprinkles" containing mulitple micronutrients (Dietary Supplement)

Micronutrient sprinkles + food aid

Experimental

Children in this arm were enrolled in the food assisted program, and therefore received fortified food aid, as well as 60 sachets of a multiple micronutrient powder (Sprinkles) containing iron, zinc, vitamin A, vitamin C and folic acid

干预措施: Education/communication on use of micronutrient sprinkles (Behavioral)

Micronutrient sprinkles + food aid

Experimental

Children in this arm were enrolled in the food assisted program, and therefore received fortified food aid, as well as 60 sachets of a multiple micronutrient powder (Sprinkles) containing iron, zinc, vitamin A, vitamin C and folic acid

干预措施: Fortified food aid (corn-soy blend) (Dietary Supplement)

结局指标

主要结局

Prevalence of anemia after 2 months of treatment

次要结局

  • Prevalence of symptoms of morbidity at 1 and 2 months after treatment begins

研究者

研究点 (1)

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