Clinical trial NCT01199445: Efficacy of Vitamin A in Fortified Extruded Rice in School Children
Official title: Efficacy of Vitamin A in Fortified Extruded Rice in School Children in Satun, Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vitamin A Deficiency
Keywords: vitamin A deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Mahidol University
name: University of Wisconsin, Madison
First posted: 2010-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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 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

Primary outcomes:
measure: Vitamin A in the entire body
timeFrame: 4 months
Secondary outcomes:
measure: Serum retinol
timeFrame: 2 months
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Tessaban 3 School
state: Satun
Study officials:
affiliation: Swiss Federal Institute of Technology (ETH,Zurich)
name: Richard F Hurrell, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinkaew S, Wegmuller R, Wasantwisut E, Winichagoon P, Hurrell RF, Tanumihardjo SA. Triple-fortified rice containing vitamin A reduced marginal vitamin A deficiency and increased vitamin A liver stores in school-aged Thai children. J Nutr. 2014 Apr;144(4):519-24. doi: 10.3945/jn.113.182998. Epub 2014 Feb 5.