Efficacy of Vitamin A in Fortified Extruded Rice in School Children
Information source: Swiss Federal Institute of Technology
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin A Deficiency
Intervention: Triple fortified extruded tice (Fe, Zn and vitamin A) (Dietary Supplement)
Phase: Phase 0
Status: Completed
Sponsored by: Swiss Federal Institute of Technology Official(s) and/or principal investigator(s): Richard F Hurrell, Ph.D, Principal Investigator, Affiliation: Swiss Federal Institute of Technology (ETH,Zurich)
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.
Clinical Details
Official title: Efficacy of Vitamin A in Fortified Extruded Rice in School Children in Satun, Thailand
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Vitamin A in the entire body
Secondary outcome: Serum retinol
Detailed description:
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..
Eligibility
Minimum age: 8 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Tessaban 3 School, Muang, Satun 91000, Thailand
Additional Information
Starting date: August 2010
Last updated: June 29, 2012
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