Fortified Rice for School Children in Cambodia (FORISCA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Institut de Recherche pour le Developpement.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
World Food Program Cambodia
PATH
Information provided by (Responsible Party):
Frank Wieringa, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT01706419
First received: October 11, 2012
Last updated: October 12, 2012
Last verified: October 2012

October 11, 2012
October 12, 2012
October 2012
July 2013   (final data collection date for primary outcome measure)
  • Anthropometry [ Designated as safety issue: No ]
    Weight, height and skinfold thickness
  • Micronutrient status [ Designated as safety issue: No ]
    iron, zinc, iodine and vitamin A status using plasma and urine concentrations
  • Cognition [ Designated as safety issue: No ]
    Raven's colored matrices test and WISC III tests
  • absentism [ Designated as safety issue: No ]
    days out of class
  • morbidity [ Designated as safety issue: No ]
    days and number of episodes ill
Same as current
Complete list of historical versions of study NCT01706419 on ClinicalTrials.gov Archive Site
  • Parasite infestation [ Designated as safety issue: No ]
    number of parasite eggs in stools
  • gut inflammation [ Designated as safety issue: No ]
    calprotectin concentrations in stool samples
Same as current
Not Provided
Not Provided
 
Fortified Rice for School Children in Cambodia
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Micronutrient Status
  • Dietary Supplement: Fortified rice cold extruded kernel
  • Dietary Supplement: fortified rice warm extruded kernel
  • Dietary Supplement: fortiified rice hot extruded kernel
  • 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
    Intervention: Dietary Supplement: Fortified rice cold extruded kernel
  • Experimental: warm extrusion
    school meal with fortified rice using warm extrusion kernels
    Intervention: Dietary Supplement: fortified rice warm extruded kernel
  • Experimental: hot extruded
    school meal with fortified rice using hot extrusion kernels
    Intervention: Dietary Supplement: fortiified rice hot extruded kernel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
6 Years to 14 Years
Yes
Contact: Frank Wieringa, MD PhD +85592750925 franck.wieringa@ird.fr
Cambodia
 
NCT01706419
FORISCA
Yes
Frank Wieringa, Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement
  • Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
  • World Food Program Cambodia
  • PATH
Principal Investigator: Frank T Wieringa, MD PhD Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP