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
  Purpose

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.


Condition Intervention
Micronutrient Status
Dietary Supplement: Fortified rice cold extruded kernel
Dietary Supplement: fortified rice warm extruded kernel
Dietary Supplement: fortiified rice hot extruded kernel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fortified Rice for School Children in Cambodia: Effects on Micronutrient Status, Growth, Cognition and Health.

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 10000
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706419

Contacts
Contact: Frank Wieringa, MD PhD +85592750925 franck.wieringa@ird.fr

Locations
Cambodia
Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration Recruiting
Phnom Penh, Cambodia
Sub-Investigator: Khov Kuong         
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
World Food Program Cambodia
PATH
Investigators
Principal Investigator: Frank T Wieringa, MD PhD Institut de Recherche pour le Developpement
  More Information

No publications provided

Responsible Party: Frank Wieringa, Senior Researcher, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT01706419     History of Changes
Other Study ID Numbers: FORISCA
Study First Received: October 11, 2012
Last Updated: October 12, 2012
Health Authority: Cambodia: Ministry of Health

Keywords provided by Institut de Recherche pour le Developpement:
vitamin A
iron
zinc
school children
fortified rice
morbidity
growth

ClinicalTrials.gov processed this record on October 29, 2014