Clinical Trial: Efficacy of Vitamin A in Fortified Extruded Rice in School Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Swiss Federal Institute of Technology

Current Primary Outcome: Vitamin A in the entire body [ Time Frame: 4 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Serum retinol [ Time Frame: 2 months ]

Original Secondary Outcome: Same as current

Information By: Swiss Federal Institute of Technology

Dates:
Date Received: August 20, 2010
Date Started: August 2010
Date Completion:
Last Updated: January 5, 2016
Last Verified: June 2012