Efficacy of Vitamin A in Fortified Extruded Rice in School Children

Vitamin A Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199445
• Other study ID #: ETH2010/SP02
• Status: Completed
• Phase: Phase 0
• First received: August 20, 2010
• Last updated: January 5, 2016
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionThailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

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.

Locations

Country	Name	City	State
Thailand	Tessaban 3 School	Muang	Satun

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Mahidol University, University of Wisconsin, Madison

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Serum retinol		2 months	No