Fortified Rice for School Children in Cambodia (FORISCA)

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.

Study Overview

• Status: Completed
• Conditions: Micronutrient Status
• Intervention / Treatment: Dietary supplement: Fortified rice cold extruded kernel; Dietary supplement: fortified rice warm extruded kernel; Dietary supplement: fortiified rice hot extruded kernel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no school meal; control group receiving no school meal
Placebo Comparator: normal school meal; school meal without fortified rice, placebo group
Experimental: cold extruded fortified rice; school meal with fortified rice using cold extrusion kernels	Dietary supplement: Fortified rice cold extruded kernel
Experimental: warm extrusion; school meal with fortified rice using warm extrusion kernels	Dietary supplement: fortified rice warm extruded kernel
Experimental: hot extruded; school meal with fortified rice using hot extrusion kernels	Dietary supplement: fortiified rice hot extruded kernel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometry	Weight, height and skinfold thickness	6 months
Micronutrient status	iron, zinc, iodine and vitamin A status using plasma and urine concentrations	6 months
Cognition	Raven's colored matrices test and WISC III tests	6 months
absentism	days out of class	6 months
morbidity	days and number of episodes ill	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parasite infestation	number of parasite eggs in stools	6 months
gut inflammation	calprotectin concentrations in stool samples	6 months

Collaborators and Investigators

• Sponsor: Institut de Recherche pour le Developpement
• Collaborators: PATH; Department of Fisheries Post-harvest Technologies and Quality Control; World Food Program Cambodia
• Investigators: Principal Investigator: Frank T Wieringa, MD PhD, Institut de Recherche pour le Developpement

Publications and helpful links

General Publications

• de Gier B, Campos Ponce M, Perignon M, Fiorentino M, Khov K, Chamnan C, de Boer MR, Parker ME, Burja K, Dijkhuizen MA, Berger J, Polman K, Wieringa FT. Micronutrient-Fortified Rice Can Increase Hookworm Infection Risk: A Cluster Randomized Trial. PLoS One. 2016 Jan 6;11(1):e0145351. doi: 10.1371/journal.pone.0145351. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: growth; zinc; morbidity; iron; vitamin A; fortified rice; school children
• Other Study ID Numbers: FORISCA