Efficacy of Vitamin A in Fortified Extruded Rice in School Children

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin A Deficiency
• Intervention / Treatment: Dietary supplement: Triple fortified extruded tice (Fe, Zn and vitamin A)

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..

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Satun
    • Muang, Satun, Thailand, 91000
      • Tessaban 3 School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: triple fortified extruded rice	Dietary supplement: Triple fortified extruded tice (Fe, Zn and vitamin A); 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.
OTHER: regular meal; regular vitamin A meal	Dietary supplement: Triple fortified extruded tice (Fe, Zn and vitamin A); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin A in the entire body	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.	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum retinol	2 months

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: University of Wisconsin, Madison; Mahidol University
• Investigators: Principal Investigator: Richard F Hurrell, Ph.D, Swiss Federal Institute of Technology (ETH,Zurich)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (ESTIMATE): September 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: vitamin A deficiency
• Additional Relevant MeSH Terms: Eye Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Night Blindness; Vitamin A Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: ETH2010/SP02