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Micronutrient StatusFORISCANCT01706419

Fortified Rice for School Children in Cambodia

A study testing Fortified rice cold extruded kernel, fortified rice warm extruded kernel and fortiified rice hot extruded kernel in people with Micronutrient Status, run by Institut de Recherche pour le Developpement at 1 site in Cambodia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Micronutrient Status
What is being tested?
Fortified rice cold extruded kernel, fortified rice warm extruded kernel and fortiified rice hot extruded kernel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9,500 participants
Where
1 siteCambodia
Study dates
Oct 2012to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Cambodia1 site
  • Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration

    Phnom Penh

Other trials in Cambodia

About this study

Official title: 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.

Read the 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.

Being tested
Fortified rice cold extruded kernel, fortified rice warm extruded kernel, fortiified rice hot extruded kernel
Keywords
vitamin A, iron, zinc, school children, fortified rice, morbidity, growth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fortified rice cold extruded kernelDietary supplement

  • fortified rice warm extruded kernelDietary supplement

  • fortiified rice hot extruded kernelDietary supplement

Study groups in NCT01706419
Study groupRoleWhat they receive
no school mealNo interventioncontrol group receiving no school meal
normal school mealPlacebo comparatorschool meal without fortified rice, placebo group
cold extruded fortified riceExperimentalschool meal with fortified rice using cold extrusion kernels
Receives: Dietary Supplement: Fortified rice cold extruded kernel
warm extrusionExperimentalschool meal with fortified rice using warm extrusion kernels
Receives: Dietary Supplement: fortified rice warm extruded kernel
hot extrudedExperimentalschool meal with fortified rice using hot extrusion kernels
Receives: Dietary Supplement: fortiified rice hot extruded kernel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anthropometry

    Weight, height and skinfold thickness

    Measured: 6 months

  2. Micronutrient status

    iron, zinc, iodine and vitamin A status using plasma and urine concentrations

    Measured: 6 months

  3. Cognition

    Raven's colored matrices test and WISC III tests

    Measured: 6 months

  4. absentism

    days out of class

    Measured: 6 months

  5. morbidity

    days and number of episodes ill

    Measured: 6 months

Secondary outcomes (2)
  1. Parasite infestation

    number of parasite eggs in stools

    Measured: 6 months

  2. gut inflammation

    calprotectin concentrations in stool samples

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706419
Sponsor's protocol ID
FORISCA
Acronym
FORISCA
Status last verified
Dec 2014
First submitted
11 Oct 2012
Last updated
18 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38890302
  • 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.

    PubMed 26735845

Questions about this trial

What is this clinical trial studying?

A study testing Fortified rice cold extruded kernel, fortified rice warm extruded kernel and fortiified rice hot extruded kernel in people with Micronutrient Status, run by Institut de Recherche pour le Developpement at 1 site in Cambodia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anthropometry (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01706419, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.

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