Micronutrient Status Clinical Trial
Official title:
Fortified Rice for School Children in Cambodia: Effects on Micronutrient Status, Growth, Cognition and Health.
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.
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.
Potential benefits of the study includes the immediate treatment of school children found to
have severe anemia (hemoglobin < 70 g/L) and improved health and cognitive development for
all children receiving fortified rice. Potential disadvantages and risks of the study
include side effects of blood taking in the subgroup of children and the disruption of
classes for a few days during the data collection.
If the results of the study show improved health and cognition for school children receiving
fortified rice, provision of fortified rice to all 500,000 Cambodian school children taking
part in the WFP school meal program in Cambodia could become a priority.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06081114 -
Micronutrient Dose Response Study in Bangladesh
|
N/A |