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临床试验/NCT01706419
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Fortified Rice for School Children in Cambodia: Effects on Micronutrient Status, Growth, Cognition and Health.

Institut de Recherche pour le Developpement1 个研究点 分布在 1 个国家目标入组 9,500 人开始时间: 2012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
9,500
试验地点
1
主要终点
Anthropometry

研究概览

简要总结

Rice fortification has been shown to be safe and effective in improving micronutrient status in many studies around the world. However, most studies have been done in Latin America, Africa and India. There are no studies available from Cambodia. Moreover, there is no data available on whether fortified rice can reduce the prevalence of anemia in school children in Cambodia, nor whether there will be additional benefits, such as better learning capability of school children or fewer days missed due to better health. To inform WFP, Cambodian policy and the public on the potential benefits of fortified rice on health and development for Cambodian school children, an intervention study will be conducted in Kampung Speu province during the 2012 - 2013 school year. The study will be conducted by IRD, PATH and WFP. Sixteen schools will be selected to receive either the normal rice provided by the WFP school meal program, or fortified rice instead of normal rice. Three (3) different types of fortified rice will be tested, to identify the best type of fortified rice. In addition, 4 schools with no school meal program will be selected to serve as control. School attendance and morbidity will be followed in all children in the participating schools over the whole school year. Biochemical indicators of micronutrient status will be determined in a subgroup of children (25% of the children), which requires collection of blood, urine and stool samples.

详细描述

Micronutrient deficiencies are a major health problem in many developing countries, including Cambodia. Micronutrient deficiency results in poor health, with a much higher risk for mortality in vulnerable groups such as pregnant women and young infants, and delayed physical and cognitive development, resulting in retarded growth and stunting. It thereby prevents children from reaching their full potential as micronutrients play an important role in children's cognitive and motor development.

The UN World Food Program (WFP) provides a daily school meal to ~500,000 school children in Cambodia. The main objective of the school meal program is to increase school attendance. Although the school meal provides salt fortified with iodine, and vegetable oil fortified with vitamin A, the school meal provides an excellent opportunity to improve micronutrient status of school children by providing them with rice fortified with vitamins and minerals such as zinc, vitamin A, iron, folic acid and vitamin B12. This is likely to reduce the prevalence of anemia in school children and improve health and school performance. Anemia is a major problem in school children in Cambodia. A recent study by WFP showed that more than half of the school children were anemic.

Rice fortification has been shown to be safe and effective in improving micronutrient status in many studies. However, most studies have been done in Latin America, Africa and India. There are no studies available from Cambodia, except for an acceptability study of fortified rice conducted by WFP and the Institute of Research for Development (IRD) in 2010 in Kampung Speu. This acceptability study showed that fortified rice has an excellent acceptability among school children, parents and teachers. However, there is no data available on whether fortified rice can reduce the prevalence of anemia in school children in Cambodia, nor whether there will be additional benefits, such as better learning capability of school children or fewer days missed due to better health.

To inform WFP, Cambodian policy and the public on the potential benefits of fortified rice on health and development for Cambodian school children, an intervention study will be conducted in Kampung Speu province during the 2012 - 2013 school year. The study will be conducted by IRD, PATH and WFP. Sixteen (16) schools will be selected to receive either the normal rice provided by the WFP school meal program, or fortified rice instead of normal rice. Three (3) different types of fortified rice will be tested, to identify the best type of fortified rice. In addition, 4 schools with no school meal program will be selected to serve as control. School attendance and morbidity will be followed in all children in the participating schools over the whole school year. Biochemical indicators of micronutrient status will be determined in a subgroup of children (25% of the children), which requires collection of blood, urine and stool samples.

The study will be submitted to the Ethical Committee of the Ministry of Health for approval, and the Ethical Review Board of PATH, USA. Furthermore, approval will be obtained from the Ministries of Health, Education and Planning prior to the commencement of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • signed informed consent by parent / caretaker
  • age between 6 and 14 yrs
  • visiting selected school
  • taking part in school meal program

排除标准

  • any chronic illness affecting growth (such as HIV)
  • no informed consent
  • severe anemia which will require direct treatment

结局指标

主要结局

Anthropometry

时间窗: 6 months

Weight, height and skinfold thickness

Micronutrient status

时间窗: 6 months

iron, zinc, iodine and vitamin A status using plasma and urine concentrations

Cognition

时间窗: 6 months

Raven's colored matrices test and WISC III tests

absentism

时间窗: 6 months

days out of class

morbidity

时间窗: 6 months

days and number of episodes ill

次要结局

  • gut inflammation(6 months)
  • Parasite infestation(6 months)

研究者

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

Frank Wieringa

Senior Researcher

Institut de Recherche pour le Developpement

研究点 (1)

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