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Completed

NCT Number: NCT01199445

Efficacy of Vitamin A in Fortified Extruded Rice in School Children

The project aims to evaluate the potential impact triple fortified rice grains, mixed into natural rice grains, can have on vitamin A status if fed to school children in Southern Thailand. Within a 60 day intervention study, changes in vitamin A status in young children fed the fortified rice compared to children consuming non-fortified rice will be assessed.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Tessaban 3 School

Muang, Changwat Satun, 91000, Thailand

About this study

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in developing countries of South and Southeast Asia. Rice is a common staple for a large part of these sub-regions of Asia. In spite of a wide range of rice varieties eaten, rice is eaten by all age groups and is one of the first few foods used as complementary food for infants.

Fe fortification of rice using a method of heat extrusion and micronized ferric pyrophosphate (FePP) as iron fortificant has shown to be efficacious in increasing iron stores and reducing the prevalence of iron deficiency in Indian school children. Subsequent extrusion trials have shown promising results with respect to color and vitamin A (VA) stability when rice grains were triple fortified with Fe, Zn and vitamin A.

Preliminary data in the region of Satun, South Thailand, have shown that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. Since rice is the main staple food in this area, rice triple fortified with Fe, VA and Zn is a promising strategy to combat micronutrient deficiencies in children.

The aim of this study is to demonstrate whether triple fortified rice has an impact on vitamin A status of children. The study will be conducted in school children (8 to 12 years old). The children will be randomized to either receive a daily lunch rice meal prepared from fortified rice (the triple fortified rice grains will be mixed into natural rice at a ratio of 1:50) or from non-fortified rice for 60 days. As serum retinol concentration, the most widely used indicator for the assessment of vitamin A status, is not a very reliable indicator due to homeostatic control and the influence of infection, we will in addition use the tracer methodology using dilution of stable isotopes with which total body vitamin A pool size will be estimated prior to the intervention and after 60 days of the intervention..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children, aged 8-12 years, both sexes, attending the local primary schools
  • No known or reported history of significant chronic illness
  • Free of acute illness and febrile and gastrointestinal problems

Exclusion criteria

  • Children with severe vitamin A deficiency with a clinical sign of Bioit's spot or ocular signs of xerophthalmia will be excluded
  • Children who have serum retinol < 0.7 umol/L

Treatment and study plan

Triple fortified extruded tice (Fe, Zn and vitamin A)

Dietary Supplement

Triple fortified extruded rice (Fe, Zn and vitamin A)will be mix at ratio of 1:50 with normal rice then give to children at school lunch meal for 60 days.

Primary outcomes

  1. Vitamin A in the entire body

    Time frame: 4 months

    A quantitative estimate of the size of exchangeable body pool of vitamin A. The exchangeable body pool of vitamin A refer to the vitamin A in body that is in dynamic state.

Secondary outcomes

  1. Serum retinol

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Mahidol University
  • University of Wisconsin, Madison

Registry information

Official study title

Efficacy of Vitamin A in Fortified Extruded Rice in School Children in Satun, Thailand

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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