Fortified Rice for School Children in Cambodia

NCT01706419 | Completed DMC

• 1 other identifier: FORISCA
• Study Type: interventional
• Target: 9,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Micronutrient Status

Keywords

vitamin A; iron; zinc; school children; fortified rice; morbidity; growth

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Parasite infestation

  6 months

• gut inflammation

  6 months

Study Arms (5)

no school meal

NO INTERVENTION

control group receiving no school meal

normal school meal

PLACEBO COMPARATOR

school meal without fortified rice, placebo group

cold extruded fortified rice

EXPERIMENTAL

school meal with fortified rice using cold extrusion kernels

Dietary Supplement: Fortified rice cold extruded kernel

warm extrusion

EXPERIMENTAL

school meal with fortified rice using warm extrusion kernels

Dietary Supplement: fortified rice warm extruded kernel

hot extruded

EXPERIMENTAL

school meal with fortified rice using hot extrusion kernels

Dietary Supplement: fortiified rice hot extruded kernel

Interventions

Fortified rice cold extruded kernel DIETARY_SUPPLEMENT

cold extruded fortified rice

fortified rice warm extruded kernel DIETARY_SUPPLEMENT

warm extrusion

fortiified rice hot extruded kernel DIETARY_SUPPLEMENT

hot extruded

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Department of Fisheries Post-harvest Technologies and Quality Control: collaborator
• World Food Program Cambodia: collaborator
• PATH: collaborator

Study Sites (1)

Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration

Phnom Penh, Cambodia

Location

Related Publications (2)

• Seyoum Y, Greffeuille V, Kouadio DKD, Kuong K, Turpin W, M'Rabt R, Chochois V, Fortin S, Perignon M, Fiorentino M, Berger J, Burja K, Ponce MC, Chamnan C, Wieringa FT, Humblot C. Faecal microbiota of schoolchildren is associated with nutritional status and markers of inflammation: a double-blinded cluster-randomized controlled trial using multi-micronutrient fortified rice. Nat Commun. 2024 Jun 18;15(1):5204. doi: 10.1038/s41467-024-49093-4.

  PMID: 38890302 DERIVED

• 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.

  PMID: 26735845 DERIVED

Study Officials

• Frank T Wieringa, MD PhD

  Institut de Recherche pour le Developpement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

CA (1)