FORISCAFortified Rice for School Children in Cambodia: Effects on Micronutrient Status, Growth, Cognition and Health.
Fortified rice cold extruded kernel
+ fortified rice warm extruded kernel
+ fortiified rice hot extruded kernel
Prevention Study
Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.9500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 to 14 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
20% chance of being blinded to the placebo group
Treatment Groups
Group I
No InterventionGroup II
PlaceboGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
Phnom Penh, CambodiaOpen Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration in Google Maps